Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific is recalling specific batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The affected catheters may not function properly during angiographic 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: This is an FDA Class I recall of a critical cardiac catheter with confirmed material delamination and mechanical failure. Per the rubric, FDA Class I recalls cannot score below 4 (Severe).
Plain-English summary
Boston Scientific Corporation is recalling specific batches of Expo 5F Selective Angiographic Catheters (Model 5F EXPO JIG4) used in cardiac angiographic procedures. The recall affects batches 60500256 and 60536210, distributed worldwide including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
The catheters are being recalled due to an increase in complaints regarding polyurethane layer delamination and material detachment in the device's inner lining. This damage prevents the guidewire from advancing properly through the catheter lumen, compromising the device's ability to perform its intended angiographic function.
Patients or healthcare providers who have received these catheters should immediately stop use and contact Boston Scientific or their physician for guidance. Healthcare facilities should check their inventory against the affected batch numbers and quarantine any affected units.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- polyurethane-delamination
- material-detachment
- guidewire-advancement-failure
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 (3)
- UDI/DI 08714729886143
- Batch Numbers: 60500256
- 60536210
Distribution
Distribution scope not specified by the agency.
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