Expo 5F Selective Angiographic Catheters Recalled for Polyurethane Delamination
Expo 5F Selective Angiographic Catheters are recalled because polyurethane layer delamination and material detachment prevent guidewire advancement. Approximately 297,479 affected catheters have been distributed worldwide.
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, which mandates a minimum severity score of 4 per the rubric. No deaths or serious injuries have been reported, so the score does not escalate to 5.
Plain-English summary
Boston Scientific Corporation is recalling certain Expo 5F Selective Angiographic Catheters (Model 5F EXPO FR4, UDI/DI 08714729187691) due to evidence of polyurethane layer delamination and material detachment in the device's inner lining. Affected catheters exhibit an inability to advance the guidewire through the device lumen.
The recall involves multiple batch numbers and affects approximately 297,479 catheters distributed worldwide to the United States, U.S. Territories, Europe, Canada, Latin America, and Asia Pacific regions.
Healthcare providers should cease use of affected catheter batches and contact Boston Scientific and the FDA for device return procedures and replacement instructions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- polyurethane-delamination
- device-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 (20)
- UDI/DI 08714729187691
- Batch Numbers: 60423767
- 60436637
- 60449962
- 60467488
- 60481586
- 60500723
- 60423768
- 60438203
- 60449964
- 60467118
- 60481588
- 60500724
- 60423772
- 60438204
- 60449961
- 60467489
- 60482882
- 60500725
- 60425130
Distribution
Distribution scope not specified by the agency.
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