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Boston Scientific Corporation recall records

352 reported ongoing

354 records in this archive. Latest source date Aug 6, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Aug 1, 2024FDA device enforcement

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 esophagea...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 esophagea...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 esophagea...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 esophagea...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 esophagea...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 esophagea...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 ...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 i...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 i...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 i...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 i...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 i...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 i...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

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 i...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Aug 1, 2024FDA device enforcement

AGILE ESO FC RMV 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 ...

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Official source

Jul 18, 2024FDA device enforcement

Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Class IIReported ongoing

Distribution: US, Colombia, Philippines, Russia

Official source

Jul 18, 2024FDA device enforcement

Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Class IIReported ongoing

Distribution: US, Colombia, Philippines, Russia

Official source

Jul 18, 2024FDA device enforcement

Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Class IIReported ongoing

Distribution: US, Colombia, Philippines, Russia

Official source

Jul 18, 2024FDA device enforcement

vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid colle...

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Class IIReported ongoing

Distribution: US, Colombia, Philippines, Russia

Official source

Jul 18, 2024FDA device enforcement

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.

There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

Class IIReported ongoing

Distribution: US, Colombia, Philippines, Russia

Official source

Reasons in these listed records

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.

These examples come from this result page and are not a ranking of every recall reason.

Checking Boston Scientific Corporation

Is there a recall on boston scientific corporation right now?

This archive contains 354 records, including 352 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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