Boston Scientific Expo 5F Catheters recalled due to material delamination defect
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures.
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 recall is classified as FDA Class I, the most serious classification for medical devices, which mandates a minimum severity score of 4. Although no illnesses or injuries have been reported, the polyurethane delamination and material detachment can prevent proper guidewire advancement in cardiac catheters used during critical interventional procedures.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO CLS4, Ref H74908526575A2) due to a manufacturing defect affecting certain batches.
The catheters contain polyurethane inner linings that can delaminate and detach from the device structure. This defect can prevent the guidewire from advancing properly through the catheter lumen, potentially compromising procedure efficacy and patient safety.
The recall affects 95 units distributed worldwide, including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. The defect has been identified in batch 60442614.
Physicians and healthcare facilities using these catheters should discontinue use of affected units immediately. Boston Scientific is contacting healthcare providers directly. Consult the FDA and Boston Scientific for specific instructions regarding replacement or return of recalled devices.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 95
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 (2)
- UDI/DI 08714729812227
- Batch Numbers: 60442614
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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