Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516700
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3275-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516710
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3276-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516720
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3277-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516730
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3278-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516740
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3279-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516750
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3280-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516900
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3281-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516910
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3282-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516920
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3283-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516930
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3284-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516940
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3285-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas
Material Number (UPN): M00516950
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3286-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic
malignant tumors, and occlusion of concurrent esophageal fistulas.
Material Number (UPN): M00517710
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3287-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic
malignant tumors, and occlusion of concurrent esophageal fistulas.
Material Number (UPN): M00517720
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3288-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic
malignant tumors, and occlusion of concurrent esophageal fistulas.
Material Number (UPN): M00517730
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3289-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic
malignant tumors, and occlusion of concurrent esophageal fistulas.
Material Number (UPN): M00517740
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3290-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic
malignant tumors, and occlusion of concurrent esophageal fistulas.
Material Number (UPN): M00517760
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3291-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic
malignant tumors, and occlusion of concurrent esophageal fistulas.
Material Number (UPN): M00517780
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3292-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic
malignant tumors, and occlusion of concurrent esophageal fistulas.
Material Number (UPN): M00517790
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3293-2024 Open, ClassifiedPosted Sep 26, 2024·Initiated Aug 1, 2024
AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic
malignant tumors, and occlusion of concurrent esophageal fistulas.
Material Number (UPN): M00517800
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Root cause: Process control
Recalling firm: Boston Scientific CorporationType: Prosthesis, EsophagealDistribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.Recall #Z-3294-2024