Cardiac Catheters Recalled for Material Delamination Risk
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters worldwide due to polyurethane delamination and material detachment that prevents guidewire advancement.
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 medical device recall. The rubric mandates a minimum score of 4 for FDA Class I recalls regardless of reported illnesses. The defect directly affects a critical cardiac catheter's core function during invasive procedures.
Plain-English summary
Boston Scientific Corporation is recalling 1,669 Expo 5F Selective Angiographic Catheters (Model 5F EXPO FL6) due to a manufacturing defect affecting certain batches. The catheters' polyurethane layer has been found to delaminate and, in some cases, material detachment occurs in the catheter's inner lining.
The defect prevents proper advancement of the guidewire through the catheter lumen, compromising the device's ability to function as intended during angiographic procedures. This failure could result in procedure delays or inability to complete necessary cardiac diagnostic and interventional procedures.
The affected catheters were distributed worldwide, including to the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Affected batch numbers are: 60447163, 60464498, 60485991, 60515607, 60517314, and 60533583. The product UDI/DI is 08714729187851.
Healthcare facilities with affected inventory should immediately cease use and contact Boston Scientific for replacement units. Remaining stock should be quarantined to prevent use in patient procedures.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- catheter-delamination
- device-malfunction
- material-detachment
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 08714729187851
- Batch Numbers: 60447163
- 60464498
- 60485991
- 60515607
- 60517314
- 60533583
Distribution
Distribution scope not specified by the agency.
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