Expo 5F Cardiac Catheters recalled due to polyurethane delamination
Boston Scientific recalled 2,314 Expo 5F cardiac catheters due to polyurethane delamination in the inner lining. The defect can prevent guidewire advancement during angiographic procedures.
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: The FDA classified this as a Class I recall. Class I recalls indicate a serious potential for adverse health consequences. The polyurethane delamination and material detachment prevent guidewire advancement, compromising the catheter's core functionality during critical cardiac procedures.
Plain-English summary
Boston Scientific Corporation is recalling 2,314 Expo 5F Selective Angiographic Catheters (Model 5F EXPO WR, Reference H74908526501). The recall affects ten specific batch numbers and involves worldwide distribution including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions.
The catheters are experiencing polyurethane layer delamination and material detachment in the inner lining. This defect results in an inability to advance the guidewire through the catheter lumen, which can prevent proper device function during cardiac angiographic procedures.
Healthcare facilities and patients who received catheters in the affected batches may be impacted. The FDA classified this as a Class I recall, indicating a serious potential for adverse health consequences.
Healthcare providers should immediately discontinue use of affected catheter batches and consult the FDA safety notice for specific batch numbers. Patients who have received these devices should contact their healthcare provider for evaluation and guidance.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; 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 (16)
- UDI/DI 08714729249399
- Batch Numbers: 60429298
- 60451469
- 60459243
- 60481409
- 60535930
- 60434211
- 60454956
- 60463953
- 60490141
- 60535931
- 60436616
- 60459198
- 60463979
- 60517312
- 60536204
Distribution
Distribution scope not specified by the agency.
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