Expo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect prevents guidewire advancement through 1065 affected devices distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls never score below 4 (Severe). The defect—polyurethane delamination preventing guidewire advancement—creates risk of procedure failure or patient injury during cardiac interventions.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters, Model 5F EXPO IM 125CM, due to polyurethane layer delamination and material detachment in the catheter inner lining. The defect results in an inability to advance the guidewire through the device lumen, preventing proper function during cardiac angiographic procedures.
The recall involves 1065 catheters from batches 60444872, 60451459, 60451968, and 60511220. These devices have been distributed worldwide, including to the United States, U.S. Territories, EMEA countries, Canada, Latin America, and Asia Pacific regions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- guidewire-advancement-failure
- material-delamination
- material-detachment
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 (5)
- UDI/DI 08714729007593
- Batch Numbers: 60444872
- 60451459
- 60451968
- 60511220
Distribution
Distribution scope not specified by the agency.
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