Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material nu

FDA device recall Z-2273-2025 · posted 2025-08-08 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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.

Action taken

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 to Boston Scientific. 2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. If you are a distributor, this notice must be forwarded to your customers to ensure notification of this device removal is carried out to the end-user level. 4. Complete and return the enclosed Reply Verification Tracking Form via email: BSCFieldActionCenter@bsci.com or fax: BSC Field Action Center 1-763-415-7708. 5. Return affected devices to Boston Scientific. If you have any questions, call the Quality Systems Manager II at 763-494-1700.

Root cause

Process change control

Status

Open, Classified

Product code

NIM

Quantity affected

26,570 (1,333 US; 25,174 OUS)

Distribution

Domestic US Nationwide distribution including Puerto Rico. International distribution worldwide.

Date initiated

2025-07-07

Date posted

2025-08-08

Location

Maple Grove, MN