Expo 5F Selective Angiographic Catheters Recalled for Material Delamination
Boston Scientific is recalling Expo 5F catheters due to polyurethane delamination and material detachment preventing guidewire advancement. The recall affects approximately 16,797 catheters 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 Class I classification mandates a minimum severity score of 4. The polyurethane delamination and material detachment in the catheter's inner lining represent a device malfunction that could compromise cardiac catheterization procedures.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters, Model 5F EXPO FR3.5, due to polyurethane layer delamination and material detachment in the catheter's inner lining. The defect compromises device functionality, specifically preventing proper advancement of the guidewire through the catheter lumen. Approximately 16,797 catheters are affected, identified by UDI/DI 08714729187684 and 20 specific batch numbers.
The recalled catheters were distributed worldwide, including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Healthcare providers and patients who have received these devices should be aware of the potential risk of procedural failure or complications during angiographic procedures.
Patients and healthcare providers who have this device should contact Boston Scientific Corporation for further guidance on device replacement or management. Healthcare facilities should inventory their stock and consult with Boston Scientific regarding affected batches to ensure patient safety and prevent use of potentially defective catheters.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; 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 (20)
- UDI/DI 08714729187684
- Batch Numbers: 60425778
- 60427745
- 60438674
- 60456279
- 60465785
- 60476456
- 60427256
- 60430877
- 60440972
- 60465783
- 60472599
- 60479447
- 60427594
- 60430933
- 60449235
- 60465784
- 60474047
- 60479448
- 60474048
Distribution
Distribution scope not specified by the agency.
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