Impella
Abiomed, Inc. · Model Impella 2.5 MPC Pump Set
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Intended use: A sterile tubular device with a built-in electrically-powered axial flow pump (e.g., a micro motor with an impeller) at the distal end, designed to provide circulatory assistance to the heart by pumping blood during heart failure. It is inserted through the lumen of the aorta and into the left ventricle, surgically or percutaneously via an artery, and connected to an external control unit; it moves blood from the left ventricle to the aorta across the aortic valve. It is typically used emergently post acute myocardial infarction (AMI), electively for high-risk cardiac catheterization, for open chest surgery, and during transport between hospitals. This is a single-use device.
Key tips
- ·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
- ·Run an incoming and annual electrical safety test regardless of how niche the device is.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Follow the manufacturer's PM schedule
- ·Perform incoming and annual electrical safety testing per facility biomedical program
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- Yes
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Intracardiac circulatory assist axial-pump catheter
- FDA product classification
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Manufacturer support
- 978.777.5410 · wbolt@abiomed.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Varies by device - check the unit's own manual for facility placement guidance
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
- RECALL
Increased risk of purge leaks with Generation 1 purge cassettes.
- RECALL
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- RECALL
Device packaged in incorrect outer box carton.
- RECALL
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
- RECALL
A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- RECALL
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
- RECALL
IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
- RECALL
New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
- RECALL
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
- RECALL
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
- RECALL
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis
- RECALL
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
- RECALL
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
- RECALL
Pump may separate at the motor housing while device is explanted
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