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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

Sep 5, 2024FDA device enforcement

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, ...

Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live o...

Class IIReported ongoing

Distribution: US Nationwide distribution in Puerto Rico.

Official source

Sep 5, 2024FDA device enforcement

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes an interactive display to provide physicians with physiolog...

Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live o...

Class IIReported ongoing

Distribution: US Nationwide distribution in Puerto Rico.

Official source

Sep 5, 2024FDA device enforcement

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologi...

Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live o...

Class IIReported ongoing

Distribution: US Nationwide distribution in Puerto Rico.

Official source

Sep 5, 2024FDA device enforcement

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, ...

Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live o...

Class IIReported ongoing

Distribution: US Nationwide distribution in Puerto Rico.

Official source

Aug 1, 2024FDA device enforcement

WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophag...

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 FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophage...

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 FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophage...

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 FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophag...

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 FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophag...

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 FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophag...

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 FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esopha...

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 FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occl...

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 FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophag...

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 FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esopha...

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 ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in eso...

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 ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in es...

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 ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW 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 ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal st...

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 ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal st...

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 ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal str...

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

Reasons in these listed records

Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The B...
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

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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