Carotid WALLSTENT® M001719030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729781226), received between Mar 25, 2025 and Aug 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK UPON REMOVAL. AN 8MM X 36MM, 5F, 135CM CAROTID WALLSTENT? MONORAIL? ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT. HOWEVER, AFTER THE STENT WAS DEPLOYED, IT WAS NOTED THAT THE DEVICE BECAME STUCK ON THE GUIDEWIRE UPON REMOVAL. THE PHYSICIAN HAD TO REMOVE THE ENTIRE SYSTEM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733633 ↗
• MalfunctionMar 25, 2025Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. AN 8X36, 5F, 135CM CAROTID WALLSTENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, WHEN HALF OF THE STENT WAS DEPLOYED, IT WAS NOTED THAT THE SHAFT FRACTURED AT THE MONORAIL PORT AFTER A "SNAP" SOUND WAS HEARD. THE STENT WAS REMOVED AFTER BEING SLOWLY RESHEATHED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE STENT WAS PLACED IN THE TRANSVERSE VENOUS SINUS. THERE WAS NO VISIBLE STENOSIS, BUT THERE WAS A PRESSURE GRADIENT, SO THE NEUROSURGEON PROCEEDED TO TREAT. ADDITIONALLY, THE ANATOMY WAS NORMAL, AND NO CALCIUM WAS NOTED, BUT THE CRANIAL VAULT WAS PLACING SOME DEGREE OF EXTERNAL COMPRESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691727 ↗