Cardiac Catheters Recalled Due to Material Delamination and Guidewire Failure
Boston Scientific is recalling Expo 5F cardiac catheters due to material delamination in the inner lining that prevents guidewire advancement. The defect affects 25,617 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 a Class I FDA medical device recall with documented material defects (polyurethane delamination and detachment) that prevent proper device function during cardiac intervention. FDA Class I classification indicates a reasonable probability of serious adverse health consequences. Although no injuries or deaths are reported in the source text, functional failure of a cardiac catheter poses significant clinical risk.
Plain-English summary
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters (Model 5F EXPO IM, Reference H749085262012), used in cardiac interventional procedures. The recall was initiated due to an increase in complaints about inability to advance the guidewire through the catheter lumen. Investigation revealed polyurethane layer delamination and, in some instances, material detachment within the catheter's inner lining.
The recall affects 25,617 catheters distributed worldwide, including in the United States, US Territories, EMEA, Canada, Latin America, and Asia Pacific regions. Eighteen batch numbers are affected, as documented in the FDA recall notice. This is classified as a Class I recall by the FDA.
Healthcare providers with affected inventory should discontinue use and contact Boston Scientific for replacement or return instructions. Patients and physicians should consult the FDA's official recall notice for additional information and contact details.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- material-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 (19)
- UDI/DI 08714729187806
- Batch Numbers: 60432320
- 60447145
- 60468840
- 60491659
- 60515603
- 60523996
- 60438675
- 60459197
- 60475371
- 60495554
- 60522591
- 60533644
- 60440974
- 60467093
- 60483661
- 60504885
- 60522595
- 60536197
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27