Boston Scientific Expo 5F Cardiac Catheters Recalled for Delamination Defect
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination that prevents guidewire advancement during cardiac procedures. The recall affects 86,898 catheters 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 requires a minimum severity score of 4 per the rubric. The defect involves polyurethane delamination that prevents proper guidewire advancement through the catheter, potentially compromising critical cardiac procedures.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO MULTIPACK 145, REF H749085263012) used in cardiac catheterization procedures. The recall affects 86,898 catheters manufactured in specific batches.
The catheters exhibit polyurethane layer delamination and material detachment in the inner lining. This defect prevents the guidewire from advancing properly through the catheter lumen, which could compromise cardiac procedures that depend on guidewire advancement.
The affected catheters were distributed worldwide to the United States, U.S. Territories, Europe, Canada, Latin America, and Asia Pacific regions. A complete list of affected batch numbers is available through Boston Scientific Corporation and the FDA.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- 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 08714729187875
- Batch Numbers: 60422723
- 60442593
- 60463980
- 60477215
- 60490182
- 60504886
- 60422730
- 60442594
- 60463981
- 60477318
- 60496717
- 60509543
- 60423803
- 60449237
- 60465461
- 60478140
- 60498231
- 60532101
- 60423804
Distribution
Distribution scope not specified by the agency.
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