Cardiac Catheters Recalled Due to Defective Polyurethane Layer
Boston Scientific recalls 1,015 Expo 5F selective angiographic catheters due to polyurethane layer delamination that prevents guidewire advancement. The defect affects multiple batches 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 an FDA Class I recall, which requires a minimum severity score of 4. The defect prevents device function that could impact medical procedures, though no reported illnesses or injuries are documented in the source.
Plain-English summary
Boston Scientific Corporation is recalling 1,015 Expo 5F Selective Angiographic Catheters, MODEL 5F EXPO CLS3 (5 pack). These are cardiac catheters used during angiographic procedures.
The catheters have a manufacturing defect affecting the polyurethane layer. The polyurethane is delaminating and material is detaching from the catheter's inner lining. This defect prevents the guidewire from advancing properly through the device lumen.
The affected catheters were distributed worldwide, including the United States, U.S. Territories, EMEA region, Canada, Latin America, and Asia Pacific countries. Affected batch numbers are 60436618, 60477262, 60477325, 60535891, and 60540487.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,015
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 (6)
- UDI/DI 08714729812180
- Batch Numbers: 60436618
- 60477262
- 60477325
- 60535891
- 60540487
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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