Expo 5F Selective Angiographic Catheters recalled for guidewire advancement failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that can prevent guidewire advancement during cardiac catheterization 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 designation applies. Per the rubric, FDA Class I recalls never score below 4. While the source text does not report actual illnesses or injuries, the device malfunction hazard—inability to advance the guidewire through the catheter lumen—represents a potential risk during critical cardiac procedures.
Plain-English summary
Boston Scientific Corporation is recalling the Expo 5F Selective Angiographic Catheters (Model 5F EXPO CAS1, Reference H749085261712) due to a defect affecting certain batches. The polyurethane layer in these cardiac catheters can delaminate and detach from the inner lining, which can prevent the guidewire from advancing properly through the device during cardiac catheterization procedures.
The defect has been identified in catheter batch 60447174. These catheters have been distributed worldwide, including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Healthcare providers and medical facilities using these catheters for cardiac procedures are affected.
Healthcare professionals should discontinue use of affected batches immediately and contact Boston Scientific and their local regulatory authorities for guidance on replacement or alternatives. Patients who may have received these catheters during cardiac procedures should consult their healthcare providers if they have concerns about their treatment.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-malfunction
- material-delamination
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 (2)
- UDI/DI 08714729187776
- Batch Numbers: 60447174
Distribution
Distribution scope not specified by the agency.
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