Recall Z-2273-2025 ยท NIM Stent, Carotid
Boston Scientific Corporation
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID WALLSTENT MONORAIL 8.0-21; H749391508290 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647010 CAROTID
| Date | Aug 8, 2025 (initiated Jul 7, 2025) |
| Status | Open, Classified |
| Reason | Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention. |
| Root cause | Process change control |
| Action | On July 7, 2025, the firm sent "Urgent Medical Device Removal" customer notifications to all affected accounts either via FedEx Overnight Delivery or in person delivery by sales representatives. The letter provided customers with information about identifying the product and instructions for product segregation and return. 1. Further distribution or use of any remaining devices (Attachment 1) affected by this removal should cease immediately. Do NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned |
| Quantity | 26,570 (1,333 US; 25,174 OUS) |
| Distribution | Domestic US Nationwide distribution including Puerto Rico. International distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.