Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Failure
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment, which may prevent proper guidewire advancement during cardiac 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 Class I classification requires a minimum score of 4 per the rubric. Although no illnesses or injuries are explicitly reported, the device malfunction directly affects patient safety during critical cardiac procedures. The polyurethane delamination and material detachment prevent proper guidewire advancement, which is essential for safe catheter use.
Plain-English summary
Boston Scientific Corporation is recalling certain batches of Expo 5F Selective Angiographic Catheters (MODEL - 5F EXPO CLS3.5, Reference Number H74908526574A2). These cardiac catheters are used in angiographic procedures to visualize blood vessels and guide treatment. A total of 615 catheters across three batches (60447147, 60467099, 60492626) are affected.
The catheters have a defect involving the polyurethane layer that forms the catheter's inner lining. Reports indicate that in some devices, this layer is delaminating and material is detaching from the inner surface. This defect may prevent the guidewire from advancing smoothly through the catheter lumen during use, potentially compromising the procedure.
The affected catheters were distributed worldwide, including to the United States, U.S. Territories, Europe, Canada, Latin America, and Asia Pacific countries.
Healthcare facilities using these catheters should immediately stop use of the affected batches and contact Boston Scientific for replacement product or a return authorization. Patients who may have received treatment with affected catheters should consult with their healthcare provider.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-delamination
- device-failure
- guidewire-malfunction
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 (4)
- UDI/DI 08714729812203
- Batch Numbers: 60447147
- 60467099
- 60492626
Distribution
Distribution scope not specified by the agency.
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