Carotid WALLSTENT® M001719020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729781202), received between Feb 27, 2019 and Nov 6, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 7, 2025Class IOpen, Classified

   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.

   Z-2273-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE STENT SHORTENING OCCURRED, REQUIRING THE USE OF ANOTHER STENT. THE TARGET LESION WAS LOCATED IN THE COMMON CAROTID ARTERY. AN 8X29, 5F, 135CM CAROTID WALLSTENT SELF-EXPANDING WAS SELECTED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT HAD SHORTENING ISSUE IN THE TARGET LESION. THE PHYSICIAN USED ANOTHER CAROTID WALLSTENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487284 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT RESTENOSIS OCCURRED TWICE, REQUIRING INTERVENTION. ON (B)(6) 2022, AN 8X29 CAROTID WALLSTENT WAS IMPLANTED FOR TREATMENT. HOWEVER, DURING ROUTINE FOLLOW UP, STENT RESTENOSIS WAS NOTED TWICE. A RE-INTERVENTION WILL TAKE PLACE FOR TREATMENT. NO FURTHER COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

  Patient problems: Restenosis

  MAUDE report 21929437 ↗
• MalfunctionMay 15, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. AN 8X29, 5F, 135CM CAROTID WALLSTENT WAS SELECTED FOR USE. HOWEVER, UPON INSPECTION PRIOR TO INSERTION, IT WAS NOTED THAT THE STENT LOOKED DAMAGED OR BENT. THE DEVICE WAS REPLACED WITH A NEW 8X29 MR CAROTID WALLSTENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325968 ↗
• MalfunctionMay 9, 2024Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15APR2024. IT WAS REPORTED THAT THE STENT WAS DEFECTIVE. AN 8X29, 5F, 135CM CAROTID WALLSTENT WAS ADVANCED FOR TREATMENT. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS DEFECTIVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED STENT PARTIAL DEPLOYMENT AND STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277253 ↗
• MalfunctionFeb 9, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. AN 8X29, 5F, 135CM CAROTID WALLSTENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, FLUOROSCOPY REVEALED THAT THE STENT WAS LONGER THAN THE LENGTH OF THE LESION. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677566 ↗
• MalfunctionDec 19, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT AN ENTRAPMENT ON THE GUIDEWIRE OCCURRED. THE 40-50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT INTERNAL CAROTID ARTERY. AN 8X29, 5F, 135CM CAROTID MONORAIL WAS ADVANCED TO ASSIST IN DEPLOYING A CAROTID WALLSTENT. DEPLOYMENT WAS SUCCESSFUL, BUT THE WALLSTENT CATHETER WAS STUCK ON THE DISTAL PROTECTION DEVICE WIRE OF A NON-BSC DEVICE AND COULD NOT REMOVED, THUS, WAS ENTRAPPED. THE PHYSICIAN ATTEMPTED TO FREE THE CATHETER BY PINNING IT AND ADVANCING THE WIRE, BUT WAS UNSUCCESSFUL. THE ENTIRE SYSTEM WAS TAKEN OUT TOGETHER WITH BOTH DEVICES AS ONE UNIT. THE CATHETER REMAINED STUCK AFTER IT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER CONFIRMED THAT THERE WAS RESISTANCE ENCOUNTERED DURING THE REMOVAL OF THE STENT DELIVERY SYSTEM OVER THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360737 ↗
• InjuryJul 13, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STROKE. ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY AND AN 8X29, 5F, 135CM CAROTID WALLSTENT WAS IMPLANTED IN THE CAROTID ARTERY TO REGAIN BLOOD FLOW. THREE DAYS LATER, THE PATIENT WAS DISCHARGED. HOWEVER, THE PATIENT SUFFERED ANOTHER STROKE TWO DAYS AFTER THE DISCHARGED AND WAS ADMITTED BACK. IT WAS THEN DETERMINED THAT THE IMPLANTED STENT FAILED, RESULTING IN PLACEMENT OF TWO ADDITIONAL STENTS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion

  MAUDE report 17316782 ↗
• MalfunctionFeb 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND NEAR THE STENT. A 8X29, 5F, 135CM CAROTID WALLSTENT WAS SELECTED FOR USE TO TREAT THE LESION. AFTER THE DEVICE WAS FLUSHED AND REMOVED THE STYLUS, A PIECE OF STYLUS OR SOME SORT OF FOREIGN MATERIAL WAS FOUND NEAR THE STENT AND ANOTHER FLUSHING WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAROTID WALLSTENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13530154 ↗
• MalfunctionAug 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26-JUL-2019. IT WAS REPORTED THAT CATHETER BREAK BELOW THE HUB OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE GROIN. A 8X29MM, 5F, 135CM CAROTID MONORAIL STENT WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE PLASTIC OUTER CATHETER BROKE FREE FROM THE HANDLE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884701 ↗
• MalfunctionFeb 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. DURING PREPARATION A 8X29, 5F, 135CM CAROTID WALLSTENT WAS BEING REMOVED FROM THE PACKAGING. DURING REMOVAL IT WAS NOTED THAT THE CATHETER SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS TO THE PATIENT WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8376530 ↗