Boston Scientific Cardiac Catheters Recalled for Inner Lining Delamination
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the inner lining, which can prevent guidewire advancement.
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, which establishes a minimum severity of 4 per the rubric. While no illnesses or injuries are reported in the source, the polyurethane delamination and material detachment in this critical cardiac device can prevent proper device function during invasive procedures, creating serious risk to patient safety.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO MULTIPACK 145) due to delamination of the polyurethane layer and material detachment within the catheter's inner lining. These defects can prevent proper advancement of the guidewire through the device's lumen.
The affected catheters have batch numbers 60447165, 60490140, and 60490183, identified by UDI/DI 08714729249429. The recalled devices total 1,950 units and were distributed worldwide, including the United States, US Territories, EMEA countries, Canada, Latin America, and Asia Pacific regions.
Healthcare facilities should discontinue use of the affected batches immediately and contact Boston Scientific for replacement or other corrective measures. Patients with concerns about procedures performed with these catheters should consult their healthcare provider.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- delamination
- material-detachment
- 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 (4)
- UDI/DI 08714729249429
- Batch Numbers: 60447165
- 60490140
- 60490183
Distribution
Distribution scope not specified by the agency.
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