Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures.
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 FDA Class I recall carries a minimum severity score of 4 per agency policy. While the device malfunction poses risk in critical cardiac procedures, no patient deaths or serious injuries are reported in the source material.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO AR1) due to manufacturing defects affecting certain production batches. The polyurethane inner lining of these catheters can delaminate and lose material during use, compromising their structural integrity.
The defect prevents physicians from advancing guidewires through the catheter's lumen, which is essential for diagnostic and interventional cardiac procedures. Affected batch numbers include 60425143, 60448984, 60474111, 60482880, 60525062, 60427595, 60448985, 60477260, 60502674, 60530043, 60429297, 60463971, 60479435, 60511249, and 60536205.
Approximately 11,109 catheters have been distributed worldwide, including to the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Healthcare facilities should identify and quarantine affected catheters and contact Boston Scientific for replacement units.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 11,109
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 (16)
- UDI/DI 08714729187929
- Batch Numbers: 60425143
- 60448984
- 60474111
- 60482880
- 60525062
- 60427595
- 60448985
- 60477260
- 60502674
- 60530043
- 60429297
- 60463971
- 60479435
- 60511249
- 60536205
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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