Expo 5F Selective Angiographic Catheters recalled due to material delamination
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in certain batches due to polyurethane layer delamination that prevents guidewire advancement. The inner lining material may detach, making the catheters unsafe to use.
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 mandates a minimum Severe rating. The delamination and material detachment prevent guidewire advancement, creating a critical functional failure during cardiac catheterization procedures.
Plain-English summary
Boston Scientific Corporation is recalling certain batches of Expo 5F Selective Angiographic Catheters (model 5F EXPO FR5 [SGL], reference number H74908526031) due to polyurethane layer delamination. The defect causes material detachment in the inner lining of the catheters, which prevents guidewire advancement through the catheter lumen.
The affected catheters are identified by UDI/DI 08714729366478 and batch number 60466921. These catheters were distributed worldwide, including to the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
Healthcare facilities and providers using these catheters should be aware of this defect. Questions or concerns should be directed to Boston Scientific Corporation.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-delamination
- material-detachment
- 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 (2)
- UDI/DI 08714729366478
- Batch Numbers: 60466921
Distribution
Distribution scope not specified by the agency.
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