Selective Angiographic Catheters recalled for material delamination and detachment
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect 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: This is an FDA Class I recall of a cardiac catheter with a documented manufacturing defect affecting guidewire advancement. The FDA Class I classification mandates a minimum Severe rating, as the defect poses a significant risk in a high-risk medical device application despite no reported illnesses or deaths.
Plain-English summary
Boston Scientific Corporation is recalling certain Expo 5F Selective Angiographic Catheters (Model 5F EXPO AL3) used in cardiac imaging procedures. The devices contain a polyurethane inner lining that may delaminate or detach during use.
The company has received complaints that the defect prevents proper advancement of the guidewire through the catheter lumen. Delamination and material detachment can compromise the device's functionality during cardiac imaging and interventional procedures.
Approximately 1,465 catheters from five batch numbers are affected: 60448983, 60461410, 60476253, 60486049, and 60517315. The devices were distributed worldwide to the U.S., U.S. territories, Europe, Canada, Latin America, and Asia Pacific regions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-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 (6)
- UDI/DI 08714729187721
- Batch Numbers: 60448983
- 60461410
- 60476253
- 60486049
- 60517315
Distribution
Distribution scope not specified by the agency.
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