Expo Cardiac Catheters Recalled Due to Polyurethane Delamination and Material Detachment
Boston Scientific's Expo 5F Selective Angiographic Catheters are being recalled worldwide because the polyurethane layer is delaminating and detaching from the inner lining, preventing the guidewire from advancing through the device.
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 is a Class I recall, the FDA's highest-risk classification, requiring a minimum severity rating of Severe per the rubric. The confirmed material delamination and inability to advance the guidewire represents a serious device malfunction that prevents medical procedures from being performed, though no patient injuries or deaths have been reported.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO TIG4, REF H749085262502) worldwide. The recall affects approximately 4,270 catheters distributed across the United States, US Territories, EMEA, Canada, LATAM, and Asia Pacific regions.
An increase in complaints has been reported regarding an inability to advance the guidewire through the catheter's lumen. Investigation revealed that the polyurethane layer in the catheters is delaminating and, in some cases, material from the inner lining is detaching.
Healthcare providers and institutions that have received these catheters should stop using the affected batches immediately. Users should reference the specific batch numbers provided: 60447162, 60461412, 60474054, 60486303, 60495529, 60511248, 60511234, and 60531435. Patients who may have received procedures with these catheters should consult with their healthcare providers.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-malfunction
- material-delamination
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 (9)
- UDI/DI 08714729886082
- Batch Numbers: 60447162
- 60461412
- 60474054
- 60486303
- 60495529
- 60511248
- 60511234
- 60531435
Distribution
Distribution scope not specified by the agency.
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