Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 17, 2025
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components:
1. Azure Astra application, Software Model Number D00U003;
2. Percepta Serena Solara application, Software Model Number D00U004;
3. Cobalt Crome application, Software Model Number D00U005;
4. Micra VR application, Software Model Number D00U006;
5. Micra AV application, Software Model Number D00U007;
6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008;
7. Claria Amplia Compia application, Software Model Number D00U009;
8. Evera MRI application, Software Model Number D00U010;
9. Visia AF application, Software Model Number D00U011;
10. Viva Brava Evera application, Software Model Number D00U012;
11. Micra VR2 AV2 application, Software Model Number D00U022.
Reason: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
Root cause: Software design
Recalling firm: Medtronic, Inc.Type: Programmer, PacemakerDistribution: WorldwideRecall #Z-2127-2025 Open, ClassifiedPosted Jul 17, 2025·Initiated Jun 17, 2025
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components:
1. Azure Astra application, Software Model Number D00U003;
2. Percepta Serena Solara application, Software Model Number D00U004;
3. Cobalt Crome application, Software Model Number D00U005;
4. Micra VR application, Software Model Number D00U006;
5. Micra AV application, Software Model Number D00U007;
6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008;
7. Claria Amplia Compia application, Software Model Number D00U009;
8. Evera MRI application, Software Model Number D00U010;
9. Visia AF application, Software Model Number D00U011;
10. Viva Brava Evera application, Software Model Number D00U012;
11. Micra VR2 AV2 application, Software Model Number D00U022.
Reason: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
Root cause: Software design
Recalling firm: Medtronic, Inc.Type: Programmer, PacemakerDistribution: WorldwideRecall #Z-2128-2025 Open, ClassifiedPosted Jul 16, 2025·Initiated Jun 30, 2025
Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.
Reason: The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Beyond Laser Systems, LLCType: High-Power Laser Light Show ProjectorDistribution: US Nationwide DistributionRecall #Z-2111-2025
Open, ClassifiedPosted Jul 16, 2025·Initiated Jun 30, 2025
Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.
Reason: The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Beyond Laser Systems, LLCType: High-Power Laser Light Show ProjectorDistribution: US Nationwide DistributionRecall #Z-2112-2025
Open, ClassifiedPosted Jul 16, 2025·Initiated Jun 30, 2025
Laser light show projectors manufactured by BLS, Model PURE 5000/10000.
Reason: The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three different hardware configurations such as the number of the number of RJ45 ports, radiant power of emissions and network configurations. No specific user manuals were provided to each model family as required by 21 CFR 1040.10(h)(1) (Informational requirements (1) User information). The Quality Control test did not validate the manual reset function to enable resumption of laser radiation emission from Class IV laser projectors after an interruption caused using a remote interlock. No supplemental product reports, as required according to 21 CFR 1002.11.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Beyond Laser Systems, LLCType: High-Power Laser Light Show ProjectorDistribution: US Nationwide DistributionRecall #Z-2113-2025
Open, ClassifiedPosted Jul 11, 2025·Initiated Jun 17, 2025
i-view video laryngoscope. Model Number: 8008000.
The i-view video laryngoscope is indicated to facilitate laryngoscopy.
Reason: Potential for faulty devices as a result of depleted batteries.
Root cause: Component design/selection
Recalling firm: Intersurgical IncType: Laryngoscope, RigidDistribution: US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.Recall #Z-2102-2025
Open, ClassifiedPosted Jul 11, 2025·Initiated Sep 19, 2023
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case.
Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI).
Reason: Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.
Root cause: Device Design
Recalling firm: NeuroSync, Inc.Type: Brain Injury Adjunctive Interpretive Oculomotor Assessment AidDistribution: United States Nationwide distribution in the states of New York (NY), Texas (TX), and Georgia (GA).Recall #Z-2114-2025
CompletedPosted Jul 11, 2025·Initiated Feb 27, 2025
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Reason: Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.
Root cause: Process control
Recalling firm: Beckman Coulter, Inc.Type: Radioassay, Vitamin B12Distribution: International distribution to the country of Andorra, Bulgaria, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Maldives, Netherlands, Portugal, Romania, Spain, Switzerland, Turkey, United Kingdom of Great Britain and Northern IrelandRecall #Z-2115-2025
Open, ClassifiedPosted Jul 11, 2025·Initiated Jun 3, 2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Reason: Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
Root cause: Process control
Recalling firm: ICU Medical, Inc.Type: Cap, Device DisinfectantDistribution: Worldwide - US Nationwide distribution including in the states of TX, SD, ID, LA, IN, CO, OK, MO, MN, OR, AZ, NC, TN, VA, CA, IL, FL, MA, OH, MD, PA, NJ, NY, WA, GA, UT, MI, MS, AR, AL, NV, KS, IA, WV, HI, KY, NM and the country of CA.Recall #Z-2116-2025
Open, ClassifiedPosted Jul 10, 2025·Initiated Jun 3, 2025
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
Reason: It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
Root cause: Process control
Recalling firm: Given Imaging Ltd.Type: Electrode, Ph, StomachDistribution: US Nationwide. Global Distribution.Recall #Z-2047-2025
Open, ClassifiedPosted Jul 10, 2025·Initiated May 14, 2025
Brand Name: Optisite Arterial Cannula
Product Name: Optisite Arterial Cannula
Model/Catalog Number: OPTI16
Software Version: N/A
Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
Component: No.
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Root cause: Under Investigation by firm
Recalling firm: Edwards Lifesciences, LLCType: Cannula, CatheterDistribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,
ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,
FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,
LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,
MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,
NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,
Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,
Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,
Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan,
Thailand, United Arab Emirates (UAE), United Kingdom.Recall #Z-2080-2025 Open, ClassifiedPosted Jul 10, 2025·Initiated May 14, 2025
Brand Name: Optisite Arterial Cannula
Product Name: Optisite Arterial Cannula
Model/Catalog Number: OPTI18
Software Version: N/A
Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
Component: No
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Root cause: Under Investigation by firm
Recalling firm: Edwards Lifesciences, LLCType: Cannula, CatheterDistribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,
ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,
FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,
LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,
MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,
NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,
Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,
Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,
Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan,
Thailand, United Arab Emirates (UAE), United Kingdom.Recall #Z-2081-2025 Open, ClassifiedPosted Jul 10, 2025·Initiated May 14, 2025
Brand Name: FEM-FLEX II
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII016A
Software Version: N/A
Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
Component: No
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Root cause: Under Investigation by firm
Recalling firm: Edwards Lifesciences, LLCType: Cannula, CatheterDistribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,
ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,
FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,
LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,
MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,
NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,
Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,
Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,
Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan,
Thailand, United Arab Emirates (UAE), United Kingdom.Recall #Z-2082-2025 Open, ClassifiedPosted Jul 10, 2025·Initiated May 14, 2025
Brand Name: FEM-FLEX II
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII016AS
Software Version: N/A
Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
Component: No
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Root cause: Under Investigation by firm
Recalling firm: Edwards Lifesciences, LLCType: Cannula, CatheterDistribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,
ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,
FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,
LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,
MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,
NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,
Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,
Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,
Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan,
Thailand, United Arab Emirates (UAE), United Kingdom.Recall #Z-2083-2025 Open, ClassifiedPosted Jul 10, 2025·Initiated May 14, 2025
Brand Name: FEM-FLEX II
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII018A
Software Version: N/A
Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
Component: No
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Root cause: Under Investigation by firm
Recalling firm: Edwards Lifesciences, LLCType: Cannula, CatheterDistribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,
ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,
FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,
LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,
MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,
NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,
Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,
Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,
Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan,
Thailand, United Arab Emirates (UAE), United Kingdom.Recall #Z-2084-2025 Open, ClassifiedPosted Jul 10, 2025·Initiated May 14, 2025
Brand Name: FEM-FLEXII
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII018AS
Software Version: N/A
Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
Component: No
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Root cause: Under Investigation by firm
Recalling firm: Edwards Lifesciences, LLCType: Cannula, CatheterDistribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,
ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,
FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,
LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,
MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,
NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,
Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,
Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,
Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan,
Thailand, United Arab Emirates (UAE), United Kingdom.Recall #Z-2085-2025 Open, ClassifiedPosted Jul 10, 2025·Initiated Jun 10, 2025
VersaCross Access Solution (VXSK),
Product Description and ID:
VXSK (180J RF WIRE 63CM/45DEG/D0)
VXSK0101
VXSK (180J RF WIRE 63CM/45DEG/D1)
VXSK0102
VXSK (180J RF WIRE 63CM/55DEG/D0)
VXSK0103
VXSK (180P RF WIRE 63CM/45DEG/D0)
VXSK0121
VXSK (180P RF WIRE 63CM/45DEG/D1)
VXSK0122
VXSK (180P RF WIRE 63CM/55DEG/D0)
VXSK0123
VXSK (180P RF WIRE 63CM/55DEG/D1)
VXSK0124
VXSK (180P RF WIRE 63CM/90DEG/D0)
VXSK0125
VXSK (230J RF WIRE 63CM/45DEG/D0)
VXSK0111
VXSK (230J RF WIRE 63CM/45DEG/D1)
VXSK0112
VXSK (230P RF WIRE 63CM/45DEG/D0)
VXSK0131
VXSK (230P RF WIRE 63CM/45DEG/D1)
VXSK0132
VXSK (230P RF WIRE 63CM/55DEG/D0)
VXSK0133
VXSK (230P RF WIRE 63CM/55DEG/D1)
VXSK0134
VXSK (230P RF WIRE 81CM/45DEG/D0)
VXSK0137
VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH
VXSK0021
VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH
VXSK0022
VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH
VXSK0024
VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH
VXSK0025
VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH
VXSK0031
VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH
VXSK0032
VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH
VXSK0034
Reason: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Root cause: Packaging change control
Recalling firm: Boston Scientific CorporationType: Catheter, SeptostomyDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.Recall #Z-2103-2025 Open, ClassifiedPosted Jul 10, 2025·Initiated Jun 10, 2025
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart.
Product ID VXW0002
Device approved and commercialized in Japan only.
Reason: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Root cause: Packaging change control
Recalling firm: Boston Scientific CorporationType: Catheter, SeptostomyDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.Recall #Z-2104-2025 Open, ClassifiedPosted Jul 10, 2025·Initiated Jun 10, 2025
VersaCross Transseptal Sheath Kit (VXS)
Product Description/IDs
VXS0201
VXS 63CM/45DEG/D0 SHEATH
VXS2112
VERSACROSS SHEATH (63CM 45DEG D0)-J
Used for the percutaneous introduction of various types of
cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal
perforation / puncture.
Reason: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Root cause: Packaging change control
Recalling firm: Boston Scientific CorporationType: Catheter, SeptostomyDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.Recall #Z-2105-2025 Open, ClassifiedPosted Jul 10, 2025·Initiated Jun 10, 2025
Torflex Transseptal Guiding Sheath Kit (TFK-M)
TF85-32-63-45
TORFLEX 8.5F 63CM 45DEG
TF85-32-63-55
TORFLEX 8.5F 63CM 55DEG
Used for the percutaneous introduction of various types of
cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
Reason: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Root cause: Packaging change control
Recalling firm: Boston Scientific CorporationType: Catheter, SeptostomyDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.Recall #Z-2106-2025