Boston Scientific Cardiac Catheters Recalled for Material Delamination
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination of the inner lining. The defect prevents guidewire advancement and affects 330 units worldwide.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the highest severity classification. FDA Class I is designated as Critical per the severity rubric and indicates a reasonable probability that the device could cause serious injury or death.
Plain-English summary
Boston Scientific Corporation is recalling 330 Expo 5F Selective Angiographic Catheters, Model 5F EXPO FR5 125CM. These cardiac catheters have been distributed worldwide, including the United States, U.S. Territories, Europe, Canada, Latin America, and Asia Pacific regions. Affected devices are identified by batch numbers 60449785, 60491507, and 60537491 (reference number H749085262302, UDI/DI 08714729007562).
An increase in complaints revealed that the polyurethane layer in the inner lining of the catheters is delaminating and in some cases material is detaching from the device. This defect prevents the guidewire from advancing through the catheter lumen. The resulting inability to advance the guidewire would prevent the angiographic procedure from being completed.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-delamination
- material-detachment
- 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 (4)
- UDI/DI 08714729007562
- Batch Numbers: 60449785
- 60491507
- 60537491
Distribution
Distribution scope not specified by the agency.
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