Carotid WALLSTENT® M001719050Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729781127), received between Jun 13, 2017 and Jul 9, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Difficult or Delayed Positioning; Entrapment of Device; Difficult or Delayed Positioning; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 10X31, 5.9F, 135CM CAROTID WALLSTENT SELF-EXPANDING STENT AND AN ENROUTE GUIDEWIRE WERE SELECTED FOR USE IN A VERIFICATION OF EFFECTIVENESS STUDY WITH PHYSICIANS IN SIMULATED BENCH MODEL. DURING DEPLOYMENT, IT WAS NOTED THAT THE STENT STICKING TO THE HOLDING SLEEVE RESULTING IN DELAY IN STENT RELEASE FROM THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS MANIPULATED, CONSEQUENTLY, THE STENT BECAME DETACHED AND STUCK IN THE GUIDEWIRE. THE WIRE REMAINS IN THE DEVICE AND WAS REMOVED WITH THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462590 ↗
• MalfunctionJun 9, 2025Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE DELIVERY SYSTEM COULD NOT BE REMOVED RESULTING TO BLOOD LOSS. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CAROTID ARTERY. A 10X31,5.9F,135CM CAROTID WALLSTENT WAS SELECTED FOR TREATMENT. HOWEVER, POST SUCCESSFUL STENT DEPLOYMENT, THE DELIVERY SYSTEM WAS STUCK ON THE NON-BOSTON SCIENTIFIC (NON-BSC) GUIDEWIRE AND COULD NOT BE REMOVED. THE DELIVERY SYSTEM AND NON-BSC WIRE WERE PULLED OUT AS ONE UNIT, AND THE WIRE ACCESS WAS LOST. CONSEQUENTLY, THE PATIENT EXPERIENCED BLOOD LOSS. THERE WAS NO TREATMENT PROVIDED TO THE PATIENT, AS THE BLOOD LOSS WAS NOT SIGNIFICANT ENOUGH TO REQUIRE GIVING THE PATIENT BLOOD. THE PATIENT FULLY RECOVERED, AND THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22170630 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED WITHIN A YEAR OF IMPLANTATION, REQUIRING REINTERVENTION. A 10X31,5.9F,135CM CAROTID STENT SELF EXPANDING WAS SELECTED FOR USE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE WITH NO DEVICE ISSUES. DURING A ROUTINE FOLLOW-UP, REINTERVENTION WAS DETERMINED TO BE THE NEXT COURSE OF ACTION BECAUSE RESTENOSIS AND VESSEL OCCLUSION OCCURRED WITHIN A YEAR OF IMPLANTATION.

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 21929388 ↗
• InjuryApr 29, 2025Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RESTENOSIS OCCURRED RESULTING TO VESSEL OCCLUSION. A 10X31, 5.9F, 135CM CAROTID WALLSTENT SELF EXPANDING WAS PLACED LAST (B)(6) 2024. IN (B)(6) 2024, RESTENOSIS OCCURRED RESULTING TO VESSEL OCCLUSION. A NEW STENT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 21929381 ↗
• MalfunctionApr 11, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PATIENT EXPERIENCED BLOOD LOSS OR HEMORRHAGE. THE OVER 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CAROTID ARTERY. A 10X31,5.9F,135CM CAROTID WALLSTENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE DEVICE OVER THE NON-BOSTON SCIENTIFIC WIRE. AFTER THE STENT WAS DEPLOYED, EXTREME DIFFICULTY IN REMOVING THE DELIVERY SYSTEM WAS NOTED. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED, BUT THE PATIENT HAD A BLOOD LOSS AS A RESULT OF THIS EVENT. THE STENT REMAINS IMPLANTED, AND THE PATIENT FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21829796 ↗
• MalfunctionApr 11, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THAT EXTREME RESISTANCE OCCURRED WHILE RETRACTING THE DEVICE, CAUSING AN INCREASE OF BLOOD LOSS. THE >75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CAROTID ARTERY. A 10X31,5.9F,135CM CAROTID WALLSTENT SELF-EXPANDING STENT WAS ADVANCED OVER THE NON-BOSTON SCIENTIFIC WIRE WITH RESISTANCE. EVENTUALLY, THE STENT WAS SUCCESSFULLY PLACED. DURING POST DEPLOYMENT, THE PHYSICIAN EXPERIENCED EXTREME RESISTANCE WHILE RETRACTING THE DELIVERY SYSTEM. THE PHYSICIAN KEEPS PULLING UNTIL THE DELIVERY SYSTEM CAME OUT, CAUSING AN INCREASE OF BLOOD LOSS. THERE WERE NO FURTHER COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21829748 ↗
• MalfunctionAug 3, 2020Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23JUL2020. IT WAS REPORTED THAT STENT DEPLOYMENT FAILURE OCCURRED. A 10X31,5.9F,135CM CAROTID WALLSTENT WAS ADVANCED FOR TREATMENT BUT FAILED TO DEPLOY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10356206 ↗
• MalfunctionApr 3, 2018Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND THEN FRACTURED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CAROTID ARTERY. THE CAROTID SHEATH WAS BACKED INTO THE AORTA. A 10X31 5.9F 135CM CAROTID WALLSTENT® WAS ADVANCED BUT FAILED TO DELIVER. AS THE PHYSICIAN PULLED THE CATHETER AND THE CAROTID STENT BACK TO THE SHEATH, THE STENT WAS PARTIALLY DEPLOYED AND BROKE OFF. THE PHYSICIAN REMOVED THE STENT HOUSING WITH THE PARTIALLY DEPLOYED STENT UP IN THE CAROTID AREA. THE SHEATH WAS PUSHED OVER THE BROKEN STENT AND THE 190CM FILTERWIRE EZ¿, WHICH HAD THE BROKEN STENT WITHIN ITS FILTER. TO PREVENT BLOOD CONTAMINATION, EVERYTHING WAS PULLED OUT AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393195 ↗
• MalfunctionJun 13, 2017Break; Break

  IT WAS FURTHER REPORTED THAT 80% STENOSED, TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED BOVINE OF AORTIC ARCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6637672 ↗