Expo Cardiac Catheters Recalled Due to Delamination and Guidewire Advancement Failure
Boston Scientific has recalled Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The defect affects certain batch numbers in 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: The FDA classified this as a Class I recall, mandating a minimum Severe rating. The defect affects critical device function in cardiac procedures but no deaths or serious injuries are reported in the source material.
Plain-English summary
Boston Scientific Corporation is recalling certain batches of Expo 5F Selective Angiographic Catheters, which are used in cardiac catheterization procedures. The recall affects 23,529 catheters, with affected units distributed worldwide including the United States, U.S. territories, EMEA, Canada, Latin America, and Asia Pacific regions.
The catheters are affected by polyurethane layer delamination and material detachment in the inner lining. This defect prevents the guidewire from advancing through the device—a critical function in cardiac catheterization. An increase in complaints about the inability to advance guidewires prompted the recall.
Healthcare facilities that use these catheters should check if they have received units from the affected batch numbers. The specific batch numbers have been identified and are available from the FDA.
Healthcare providers should contact Boston Scientific Corporation for instructions regarding affected catheters. Patients who have concerns about procedures using these catheters should consult with their healthcare provider.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-delamination
- material-detachment
- guidewire-advancement-failure
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 08714729249412
- Batch Numbers: 60437054
- 60447182
- 60463964
- 60477273
- 60488498
- 60495556
- 60437063
- 60447183
- 60465472
- 60481568
- 60488499
- 60497690
- 60437064
- 60448980
- 60465473
- 60483603
- 60488500
- 60507240
- 60438200
Distribution
Distribution scope not specified by the agency.
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