Expo 5F cardiac angiographic catheters recalled for delamination defect
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination that prevents guidewire advancement through the catheter lumen.
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 recall carries an FDA Class I classification, which establishes a minimum severity level of 4 per the rubric. While no reported deaths or serious injuries are documented in the source, the defect involves material failure in a critical cardiac intervention device that prevents proper function.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters, Model 5F EXPO FL3.5, due to polyurethane layer delamination and material detachment in the catheter's inner lining. This defect prevents the guidewire from advancing through the catheter's lumen, potentially compromising the effectiveness of cardiac angiographic procedures.
The recall affects 263,522 catheters with worldwide distribution, including the US, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Multiple batch numbers are affected, as specified in the recall documentation.
Multiple complaints have been received regarding the inability to advance guidewires through affected catheters. Healthcare providers should review their inventory of affected units and consult Boston Scientific Corporation for further guidance on managing recalled devices.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-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 (20)
- UDI/DI 08714729187813
- Batch Numbers: 60423725
- 60438648
- 60449984
- 60474078
- 60488293
- 60507284
- 60427729
- 60438649
- 60453725
- 60474079
- 60490173
- 60507287
- 60427730
- 60440943
- 60453726
- 60474080
- 60490174
- 60507479
- 60427731
Distribution
Distribution scope not specified by the agency.
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