Carotid WALLSTENTRecalls & reported problems across all models

We found 7 models of Carotid WALLSTENT by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2017 and Aug 5, 2026 — classified as 7 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Defective Device” (6 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Carotid WALLSTENT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 7, 2025Open, 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 · names 7 of these models · Recall details · FDA record ↗

Most reported Carotid WALLSTENT problems

Carotid WALLSTENT models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Carotid WALLSTENT® M001719020

  STENT, CAROTID
  1 recall10 reports
• Carotid WALLSTENT® M001719050

  STENT, CAROTID
  1 recall9 reports
• Carotid WALLSTENT® M001719060

  STENT, CAROTID
  1 recall7 reports
• Carotid WALLSTENT® M001719040

  STENT, CAROTID
  1 recall4 reports
• Carotid WALLSTENT® M001719030

  STENT, CAROTID
  1 recall2 reports
• Carotid WALLSTENT® M001719010

  STENT, CAROTID
  1 recall1 report
• Carotid WALLSTENT® M001719000

  STENT, CAROTID
  1 recall0 reports

Recent Carotid WALLSTENT adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗

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