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

FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac ca...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; car...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; car...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac ...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; car...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; card...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac ...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac ca...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardia...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac ...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; car...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; c...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011;...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H74908526301...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H74908526302...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H74908526500...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac cat...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac cat...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H74908526502...
FDA device enforcement

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac catheter

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Class IReported ongoing

Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official source for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H74908526511; cardiac ca...

Reasons in these listed records

  • An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

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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