Carotid WALLSTENT® M001719060Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729781141), received between Aug 31, 2022 and Mar 3, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT STENT ELONGATION OCCURRED, REQUIRING PLACEMENT OF ANOTHER STENT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CAROTID ARTERY. A 10X37,5.9F,135CM CAROTID WALLSTENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, STENT ELONGATION WAS NOTED THROUGH ANGIOGRAPHIC IMAGE. THE STENT WAS FULLY EXPANDED AND IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500673 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED ALLERGIC REACTION POST STENT IMPLANTATION. A 10X37,5.9F,135CM CAROTID WALLSTENT WAS IMPLANTED IN THE PATIENT. POST STENT IMPLANTATION, PATIENT EXPERIENCED SYSTEMIC HIVES, WELTS, ANGIOEDEMA, AND AN ANAPHYLACTIC REACTION. THE PATIENT HAD BEEN PLACED ON MANY STEROIDS AND SEEN 3 ALLERGISTS TO DATE.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 24484123 ↗
• MalfunctionSep 2, 2025Mechanical Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT WAS PARTIALLY DEPLOYED AND WAS DIFFICULT TO RECONSTRAIN. THE TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY TORTUOUS AND MODERATELY CALCIFIED CAROTID ARTERY. A 10X37,5.9F,135CM CAROTID WALLSTENT WAS SELECTED FOR USE. ACCESS WAS GAINED VIA THE FEMORAL ARTERY AND THE STENT WAS POSITIONED IN THE LESION. WHEN THE STENT WAS DEPLOYED AROUND 50%, IT WAS NOTED THAT THE T-CONNECTOR AND HEART SHAPE HUB WERE TOUCHING. THE STENT WAS NOT ABLE TO BE FULLY DEPLOYED DUE TO THIS ISSUE. IT WAS NOTED THAT WHEN THE PHYSICIAN WAS PINNING AND PULLING, IT SEEMED LIKE TENSION WAS LOST IN THE HUB AREA AND A POP WAS HEARD. THE STENT WAS RE-SHEATHED, EXCEPT FOR A SMALL PART AT THE TIP, AND THEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948241 ↗
• MalfunctionMay 27, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH A STROKE WHICH REQUIRED THE DEPLOYMENT OF TWO CAROTID WALLSTENTS. THE GREATER THAN 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CAROTID ARTERY. THE FIRST CAROTID WALLSTENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LOCATION. POST STENT DEPLOYMENT, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM BECAME STUCK WITH NON-BOSTON SCIENTIFIC WIRE. BOTH WIRE AND DELIVERY SYSTEM WERE REMOVED TOGETHER WHICH RESULTED IN A LOSS OF WIRE ACCESS. WIRE ACCESS WAS RE-ESTABLISHED WITH A NEW NON-BSC GUIDEWIRE. THE SECOND CAROTID WALLSTENT WAS ADVANCED AND DEPLOYED WITHOUT ISSUE. HOWEVER, POST-DEPLOYMENT, THE DELIVERY SYSTEM ALSO BECAME STUCK WITH THE NON-BOSTON SCIENTIFIC WIRE. BOTH THE WIRE AND DELIVERY SYSTEM WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090040 ↗
• MalfunctionMay 27, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH A STROKE WHICH REQUIRED THE DEPLOYMENT OF TWO CAROTID WALLSTENTS. THE GREATER THAN 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CAROTID ARTERY. THE FIRST CAROTID WALLSTENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LOCATION. POST STENT DEPLOYMENT, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM BECAME STUCK WITH NON-BOSTON SCIENTIFIC WIRE. BOTH WIRE AND DELIVERY SYSTEM WERE REMOVED TOGETHER WHICH RESULTED IN A LOSS OF WIRE ACCESS. WIRE ACCESS WAS RE-ESTABLISHED WITH A NEW NON-BSC GUIDEWIRE. THE SECOND CAROTID WALLSTENT WAS ADVANCED AND DEPLOYED WITHOUT ISSUE. HOWEVER, POST-DEPLOYMENT, THE DELIVERY SYSTEM ALSO BECAME STUCK WITH THE NON-BOSTON SCIENTIFIC WIRE. BOTH THE WIRE AND DELIVERY SYSTEM WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090036 ↗
• MalfunctionFeb 3, 2023Difficult or Delayed Positioning; Poor Visibility; Difficult or Delayed Positioning; Poor Visibility

  IT WAS REPORTED THAT STENT DIFFICULT TO VISUALIZE UNDER FLUOROSCOPY. THE TARGET LESION WAS LOCATED IN THE COMMON CAROTID ARTERY. A 10X37,5.9F,135CM CAROTID WALLSTENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING POST PROCEDURE, THE STENT WAS NOT DEPLOYED WELL AS THE STENT STRUT WAS HARD TO VIEW UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16295376 ↗
• MalfunctionAug 31, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED. THE 7MM TARGET LESION WAS LOCATED IN CAROTID ARTERY. A 10X37,5.9F,135CM CAROTID WALLSTENT STENT WAS IMPLANTED. HOWEVER, THE DEVICE WAS ELONGATED ABOVE THE LENGTH OF 70MM. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329009 ↗