Expo 5F Selective Angiographic Cardiac Catheters: Guidewire Advancement Failure Risk
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Cardiac Catheters due to polyurethane delamination that prevents guidewire advancement. The recall affects 15,270 units 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: FDA classified this as Class I. The defect—polyurethane layer delamination and material detachment—prevents the device from functioning as intended by blocking guidewire advancement through the catheter lumen.
Plain-English summary
Boston Scientific Corporation is recalling certain batches of the Expo 5F Selective Angiographic Catheters, a medical device used in cardiac angiographic procedures. The affected batches total 15,270 units and have been distributed worldwide, including to the United States, U.S. Territories, EMEA countries, Canada, Latin America, and Asia Pacific regions.
The catheters in the affected batches show evidence of polyurethane layer delamination and material detachment in the inner lining. This defect prevents the guidewire from advancing through the catheter lumen, preventing the device from functioning as intended during procedures.
The affected batch numbers are: 60447157, 60462032, 60480056, 60493500, 60524948, 60447158, 60477290, 60480062, 60504860, and 60533592. Users and healthcare facilities should immediately discontinue use of catheters from these batches and contact Boston Scientific for information about replacements and proper device disposition.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-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 (11)
- UDI/DI 08714729187882
- Batch Numbers: 60447157
- 60462032
- 60480056
- 60493500
- 60524948
- 60447158
- 60477290
- 60480062
- 60504860
- 60533592
Distribution
Distribution scope not specified by the agency.
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