Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding… — Class I medical device recall Z-2273-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-08-20, distributed nationwide. Certain batches are being removed due to an increase in complaints received in which physicians encountered gr
| Recall number | Z-2273-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2025-07-07 |
| Classified | 2025-08-08 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 08714729263869, 08714729263876, 08714729263883, 08714729263890, 08714729263906, 08714729263913, 08714729263920, 08714729781097, 08714729781103, 08714729781110, 08714729781127, 08714729781141, 08714729781158, 08714729781165, 08714729781172, 08714729781189, 08714729781196, 08714729781202, 08714729781226 |
| Lot numbers | 35240183, 35240184, 35240185, 35241830, 35241831, 35242395, 35243220, 35244198, 35244199, 35244520, 35244521, 35247274, 35247275, 35247276, 35247277, 35247278, 35247279, 35247540, 35247541, 35248292, 35248293, 35248294, 35252806, 35252807, 35252808, 35252809, 35252812, 35258269, 35258270, 35258273, 35258274, 35258275, 35258276, 35258277, 35258278, 35258279, 35260228, 35260229, 35260230, 35260231 and 460 more |
Product
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 WALLSTENT MONORAIL 6.0-22; H965SCH647070 CAROTID WALLSTENT MONORAIL 8.0-21; H965SCH647080 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647090 CAROTID WALLSTENT MONORAIL 8.0-36; H965SCH647120 CAROTID WALLSTENT MONORAIL 10.0-24; H965SCH647130 CAROTID WALLSTENT MONORAIL 10.0-31; H965SCH647140 CAROTID WALLSTENT MONORAIL 10.0-37; M001719000 CAROTID WALLSTENT MR 6X22 5F 135CM; M001719010 CAROTID WALLSTENT MR 8X21 5F 135CM; M001719020 CAROTID WALLSTENT MR 8X29 5F 135CM; M001719030 CAROTID WALLSTENT MR 8X36 5F 135CM; M001719040 CAROTID WALLSTENT MR 10X24 5.9F 135CM; M001719050 CAROTID WALLSTENT MR 10X31 5.9F 135CM; M001719060 CAROTID WALLSTENT MR 10X37 5.9F 135CM;
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2273-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.