Boston Scientific Expo 5F catheters recalled for material delamination
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The recall affects 46,860 units 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: This is an FDA Class I recall of a cardiac catheter with documented material delamination and device malfunction. FDA Class I recalls are scored at minimum 4 (Severe) per the rubric, a threshold maintained here despite the absence of reported illnesses or injuries.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (MODEL - 5F EXPO MULTIPACK, REF H749085263002) due to a manufacturing defect affecting the catheter lumen. The polyurethane layer of the catheter is delaminating, and in some cases material is detaching from the inner lining. This defect can prevent the guidewire from advancing through the catheter during cardiac catheterization procedures.
The recall involves 46,860 catheters from 16 specific batch numbers distributed worldwide, including the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Affected units are identified by UDI/DI 08714729187868 and specific batch numbers provided by the manufacturer.
Healthcare facilities should immediately cease use of affected batches and verify the batch numbers of units in their inventory. Physicians and patients should contact Boston Scientific for guidance on catheter replacement and alternative products.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; 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 (18)
- UDI/DI 08714729187868
- Batch Numbers: 60427727
- 60456253
- 60462030
- 60476271
- 60500758
- 60530055
- 60436627
- 60460188
- 60474027
- 60477271
- 60502673
- 60537578
- 60438198
- 60461419
- 60475349
- 60486289
- 60515228
Distribution
Distribution scope not specified by the agency.
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