Cardiac Catheters Recalled Due to Material Delamination and Guidewire Failure
Boston Scientific is recalling Expo 5F cardiac catheters due to material delamination in the inner lining that prevents guidewire advancement. The defect affects 25,617 units distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class I FDA medical device recall with documented material defects (polyurethane delamination and detachment) that prevent proper device function during cardiac intervention. FDA Class I classification indicates a reasonable probability of serious adverse health consequences. Although no injuries or deaths are reported in the source text, functional failure of a cardiac catheter poses significant clinical risk.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO IM, Reference H749085262012), used in cardiac interventional procedures. The recall was initiated due to an increase in complaints about inability to advance the guidewire through the catheter lumen. Investigation revealed polyurethane layer delamination and, in some instances, material detachment within the catheter's inner lining.
The recall affects 25,617 catheters distributed worldwide, including in the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Eighteen batch numbers are affected, as documented in the FDA recall notice. This is classified as a Class I recall by the FDA.
Healthcare providers with affected inventory should discontinue use and contact Boston Scientific for replacement or return instructions. Patients and physicians should consult the FDA's official recall notice for additional information and contact details.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 25,617
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- UDI/DI 08714729187806
- Batch Numbers: 60432320
- 60447145
- 60468840
- 60491659
- 60515603
- 60523996
- 60438675
- 60459197
- 60475371
- 60495554
- 60522591
- 60533644
- 60440974
- 60467093
- 60483661
- 60504885
- 60522595
- 60536197
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 48 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Same hazard · material delamination
See all →- SevereExpo 5F cardiac catheters recalled for material delamination worldwide
FDA (Devices) · 2024-05-22
- SevereExpo 5F Catheters Recalled for Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- SevereExpo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- SevereExpo 5F Angiographic Catheters Recalled for Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- SevereCardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
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