Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Issues
Boston Scientific is recalling 9,271 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that can prevent guidewire advancement. The defect was found in certain batches with worldwide distribution.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the agency's most serious classification level for medical devices. The polyurethane delamination causes documented device malfunction that prevents proper guidewire advancement during critical cardiac procedures.
Plain-English summary
Boston Scientific Corporation is recalling 9,271 Expo 5F Selective Angiographic Catheters (model 5F EXPO AR2) due to defects in the catheter's polyurethane lining. In certain batches, the polyurethane layer is delaminating and material is detaching from the catheter's inner lining. This defect can prevent the guidewire from advancing through the catheter's lumen, which could compromise procedures that rely on precise catheter positioning.
These catheters were distributed worldwide, including in the United States, US Territories, Europe, Canada, Latin America, and Asia Pacific regions. The affected batch numbers are 60430930, 60447169, 60462004, 60475385, 60515237, 60525060, 60447168, 60461420, 60474038, 60486305, 60522598, 60531431, and 60540176. The FDA has classified this as a Class I recall, indicating a serious potential hazard to patients.
If you have these catheters, do not use them and contact Boston Scientific for return and replacement instructions. Healthcare facilities should quarantine stock from affected batches immediately. If a catheter from an affected batch has already been used in a procedure, inform your healthcare provider.
The recalled product
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-malfunction
- delamination
- material-defect
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 (14)
- UDI/DI 08714729168874
- Batch Numbers: 60430930
- 60447169
- 60462004
- 60475385
- 60515237
- 60525060
- 60447168
- 60461420
- 60474038
- 60486305
- 60522598
- 60531431
- 60540176
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03