Selective Angiographic Catheters Recalled Due to Material Delamination
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter lining, which may prevent guidewire advancement during medical procedures.
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 classified this as a Class I recall for a cardiac catheter with material delamination and guidewire obstruction. Per the severity rubric, FDA Class I recalls are never classified below Severe (4). The device malfunction poses direct risk to cardiac procedure safety.
Plain-English summary
Boston Scientific Corporation is recalling certain batches of Expo 5F Selective Angiographic Catheters (Model 5F EXPO FR4 125CM) due to a defect in which the polyurethane layer is delaminating and material is detaching from the inner lining of the catheter. This defect prevents the guidewire from advancing properly through the device, potentially compromising the effectiveness of cardiac angiographic procedures.
The recall affects 5,435 catheters distributed worldwide, including the United States, U.S. Territories, EMEA, Canada, Latin America, and Asia Pacific regions. The affected batch numbers are: 60430691, 60447156, 60463406, 60488300, 60493468, and 60537513.
Patients and healthcare providers who possess this product should stop using it immediately. Healthcare facilities should review inventory for affected batch numbers and quarantine affected units. Contact Boston Scientific Corporation for replacement catheters or further instructions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-delamination
- guidewire-obstruction
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 (7)
- UDI/DI 08714729192817
- Batch Numbers: 60430691
- 60447156
- 60463406
- 60488300
- 60493468
- 60537513
Distribution
Distribution scope not specified by the agency.
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