Carotid WALLSTENT® M001719040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729781103), received between Jul 10, 2017 and Aug 5, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Mechanical Problem; Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141454 ↗
• MalfunctionApr 22, 2025Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED CAROTID ARTERY. A 10X24,5.9F,135CM CAROTID WALLSTENT SELF-EXPANDING WAS SELECTED FOR USE. DURING DEPLOYMENT OF ABOUT 3/4 OF THE STENT, IT WAS NOTED THAT THE SHAFT BROKE AND PARTIALLY SEPARATED. EVENTUALLY, THE STENT WAS ABLE TO BE FULLY DEPLOYED AND THE WHOLE DELIVERY CATHETER WAS ABLE TO BE PULLED OUT. THE STENT WAS IMPLANTED AND WAS NOT RE-CONSTRAIN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886746 ↗
• MalfunctionDec 16, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THE STENT WAS BENT. A CAROTID WALLSTENT WAS SELECTED FOR USE IN A CORONARY ARTERY STENTING PROCEDURE. DURING THE PROCEDURE, AFTER THE STENT PASSED THE LESION, THE STENT WAS NOT ABLE DEPLOY. THE STENT TIP WAS FOUND TO BE BENT AND WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019237 ↗
• MalfunctionJul 10, 2017Device Damaged Prior to Use; Component Missing; Device Damaged Prior to Use; Component Missing

  IT WAS REPORTED THAT THE STENT WAS MISSING. DURING PREPARATION OF A 10X24,5.9F,135CM CAROTID WALLSTENT STENT, WHEN PHYSICIAN FLUSHED THE DEVICE, IT WAS NOTED THAT THERE WAS NO STENT ON THE DEVICE. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6697280 ↗