Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment in the catheter's inner lining, which prevents proper advancement of the guidewire.
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 is the highest classification for medical device recalls. This recall involves a significant structural defect affecting device functionality, but the source does not report any patient injuries or deaths. Per the rubric, FDA Class I recalls are classified no lower than severity 4.
Plain-English summary
Boston Scientific Corporation is recalling the Expo 5F Selective Angiographic Catheters, Model 5F EXPO IMT (5PK), Reference H749085262022. The company identified an increase in complaints reporting an inability to advance the guidewire through the catheter's lumen.
The defect results from evidence of polyurethane layer delamination and, in some instances, material detachment in the catheter's inner lining. This structural failure prevents proper advancement of the guidewire during angiographic procedures.
The affected catheters have been distributed worldwide, including the U.S., U.S. Territories, EMEA countries, Canada, Latin America, and Asia Pacific regions. The recall involves 2,366 catheters from batch numbers 60447151, 60456265, 60472610, 60486304, 60522592, and 60531432 (UDI/DI 08714729249191).
Healthcare facilities that have received these catheters should contact Boston Scientific for replacement or return instructions.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 2,366
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 (7)
- UDI/DI 08714729249191
- Batch Numbers: 60447151
- 60456265
- 60472610
- 60486304
- 60522592
- 60531432
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 48 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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