WALLSTENT® Endoprosthesis H965403330Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729204053), received between Feb 11, 2019 and Dec 22, 2025 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02DEC2025. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 75CM WALLSTENT-UNI ENDOPROSTHESIS SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE STENT ALREADY DEPLOYED FROM THE DELIVERY SYSTEM AND THE STENT CUP WAS NOTED TO BE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868078 ↗
• MalfunctionDec 1, 2025Adverse Event Without Identified Device or Use Problem; Activation Failure; Adverse Event Without Identified Device or Use Problem; Activation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VEIN. A 16MM X 90MM X 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING ATTEMPTED DEPLOYMENT, THE DELIVERY SYSTEM WOULD NOT RELEASE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A DAMAGED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687800 ↗
• MalfunctionSep 9, 2024Positioning Failure; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14AUG2024. IT WAS REPORTED THAT DEPLOYMENT FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16X90/9FR 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DELIVERY SHAFT COULD NOT BE ADVANCED, AND THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DAMAGE TO THE DISTAL STENT WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168946 ↗
• MalfunctionApr 3, 2024Mechanical Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO REMOVE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL VEIN PUNCTURE. THE 50% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 16MM X 90MM X 75CM WALLSTENT ENDOPROSTHESIS WITH THE UNISTEP PLUS DELIVERY SYSTEM WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, A BALLOON WAS EXPANDED AND THEN THE STENT WAS RELEASED BUT RESISTANCE WAS ENCOUNTERED. THE STENT WAS LESS THAN 50% DEPLOYED. UPON WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE TIP OF THE STENT WAS FOUND LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033875 ↗
• MalfunctionFeb 7, 2024Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT OBVIOUS CREASE WAS FOUND IN THE STENT. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. AN 16X90/9FR WALLSTENT UNI WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER BALLOON DILATATION, AN APPARENT CREASE IN THE STENT WAS FOUND WHEN IT WAS EXTRACTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT 50% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS FEMORAL ARTERY AND THE OBVIOUS CREASE WAS LOCATED IN THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660324 ↗
• MalfunctionJan 16, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT POSITIONING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMBS. A 16X90/9FR UNI PLUS 75CM WALLSTENT UNI WAS ADVANCED TO TREAT THE LESION. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT JUMPED FORWARD TOO MUCH AFTER WITHDRAWAL, MAKING IT UNABLE TO COVER THE SITE OF THE THROMBUS. THE DEVICE WAS DIRECTLY REMOVED AND REPLACED WITH A DIFFERENT MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE STENT WAS DISPLACED UPON WITHDRAWAL OF THE DELIVERY SYSTEM. THE STENT WAS REMOVED WITHOUT BEING RE-CONSTRAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517899 ↗
• MalfunctionJan 4, 2024Tear, Rip or Hole in Device Packaging; Adverse Event Without Identified Device or Use Problem; Tear, Rip or Hole in Device Packaging; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DAMAGE ON THE INNER PACKAGE OCCURRED. A 16X90/9FR UNI PLUS 75CM WALLSTENT UNI WAS SELECTED FOR THE TREATMENT ON THE ILIAC VEIN. WHEN IT WAS UNPACKED FOR PREPARATION, A DAMAGE WAS NOTED AS THERE WAS A VISIBLE HOLE ON THE INNER PACKAGING, COMPROMISING THE DEVICE STERILITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446035 ↗
• MalfunctionAug 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF A 16X90/9FR 75CM WALLSTENT ENDOPROSTHESIS, THE STENT WAS FLUSHED AND PRE-DEPLOYED OUTSIDE THE PATIENT. HOWEVER, IT WAS NOTED THAT THE TIP OF THE STENT LOOKED ABNORMAL. THERE WAS A LARGE AMOUNT OF BURRS AND THE STENT DEPLOYED POORLY. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596227 ↗
• MalfunctionDec 14, 2022Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE PATIENT PRESENTED FOR LOWER EXTREMITY VENOUS BALLOON DILATION AND STENTING OF THE TARGET LESION LOCATED IN THE INFERIOR VENA CAVA. A16X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT AS ADVANCED FOR TREATMENT BUT COULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983245 ↗
• InjuryOct 4, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE TARGET LESION WAS LOCATED IN ILIAC VEIN. AFTER THE GUIDEWIRE WAS INSERTED AND PRE-DILATION WAS PERFORMED, A 16X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE PROXIMAL OF THE STENT WAS SHRINKED AT 1-1.5CM. THE LESION WAS OVERLAPPED WITH ANOTHER 16X90 STENT AND PRE-DILATED AGAIN WITH BALLOON CATHETER. THE VESSEL MONORLOGY WAS GOOD BUT THE PROXIMAL PART OF SECOND STENT WAS ALSO SHRINKED AT ABOUT 2CM, WHICH AFFECTED THE POSITIONING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540157 ↗
• MalfunctionSep 6, 2022Mechanical Problem; Difficult to Remove; Mechanical Problem; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL AND RE-CONSTRAIN DIFFICULTIES OCCURRED. THE PATIENT UNDERGOING ENDOVASCULAR REPAIR OF ILIAC VEIN COMPRESSION SYNDROME. A 16X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT AFTER THE PHYSICIAN DEPLOYED HALF OF THE STENT AND ADJUSTED THE STENT LOCATION, THE DEVICE FAILED TO BE RETRIEVED AND EVENTUALLY WAS REMOVED DIRECTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361485 ↗
• MalfunctionOct 7, 2021Positioning Failure; Difficult to Remove; Material Deformation; Positioning Failure; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16X90/9FR WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT ALONG WITH THE GUIDEWIRE. HOWEVER, THE STENT WAS STUCK DURING DEPLOYMENT AND WAS UNABLE TO BE DEPLOYED NOR WITHDRAWN. THE PHYSICIAN PULLED OUT THE DELIVERY SHAFT, IT WAS NOTED THAT THE STENT WAS ELONGATED AND DEFORMED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591357 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION. A 16X90/9 75CM WALLSTENT ENDOPROSTHESIS WAS IMPLANTED. HOWEVER, DURING ROUTINE FOLLOW-UP, THE PATIENT HAD A RASH THAT WAS THOUGHT TO BE AN ALLERGIC REACTION. THE PATIENT DID NOT DISCLOSE A POSSIBLE NICKEL ALLERGY PRE-PROCEDURE AND THE SYMPTOMS APPEARED AFTER SEVERAL MONTHS/YEARS OF STENT PLACEMENT. THE PATIENT WAS ADVISED TO SEE AN ALLERGIST FOR TESTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11963295 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ALLERGIC REACTION. A 16X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS IMPLANTED. HOWEVER, ON A ROUTINE FOLLOW-UP, IT WAS NOTED THAT THE PATIENT EXPERIENCED ALLERGIC REACTION WITH THE IMPLANTED DEVICE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11963292 ↗
• InjurySep 15, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT PROFILE PROBLEM WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC VEIN. A 16X90/9FR WALLSTENT UNI STENT WAS ADVANCED BUT THE DISTAL END OF THE STENT WAS RAPIDLY SHORTENED BY ABOUT 3CM, AND ANOTHER 16X90/9FR WALLSTENT UNI STENT WAS NEEDED. DURING PROCEDURE, THE VESSEL CHANGED SHAPE AFTER THE STENT WAS PLACED BECAUSE THE SHEATH WAS TOO HARD, AND THE SECOND STENT COULD NOT BE ADVANCED. THE PHYSICIAN GAVE UP CONNECTING THE STENT FOR SAFETY REASON AND REMOVED THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10537327 ↗
• MalfunctionJun 26, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 16X90/9FR UNI PLUS 75CM WALLSTENT WAS SELECTED FOR USE. HOWEVER, DURING DEPLOYMENT, THE PHYSICIAN TRIED TO RECAPTURE STENT FOR REPOSITIONING. HOWEVER, THE DEVICE DID NOT WORK CORRECTLY AND AFTER ATTEMPTS THE STENT WAS RECAPTURED AND REMOVED. THE PROCEDURE WAS RESCHEDULED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10200022 ↗
• InjuryNov 18, 2019Retraction Problem; Material Integrity Problem; Positioning Problem; Retraction Problem; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED THAT STENT RECONSTRAINING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE STENOSED ILIAC VEIN. A 16X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR TREATMENT. HOWEVER, THE STENT DEPLOYMENT LOCATION WAS NOT IN THE CORRECT LOCATION. WHEN THE PHYSICIAN ATTEMPTED TO REPOSITION THE STENT, IT COULD NOT BE RECONSTRAINED DESPITE BEING LESS THAN ONE THIRD DEPLOYED. THE STENT WAS RELEASED AND AFTER THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY, THE CATHETER WAS FOUND TO BE TWISTED. THE PHYSICIAN DEPLOYED ANOTHER OF THE SAME DEVICE TO THE DESIRED POSITION AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9337702 ↗
• MalfunctionJul 26, 2019Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE STENT WAS NOT FULLY RECONSTRAINED. A 16X90/9 FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT SELF EXPANDING CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, AS THEY PULLED THE SHEATH BACK TO DELIVER THE STENT, THE STENT SLID BACK WITH THE SHEATH. THE STENT WAS RECONSTRAINED; HOWEVER A PART WAS STILL EXPOSED AT THE TIME OF REMOVAL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8831765 ↗
• InjuryJul 18, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE STENT FAILED TO FULLY EXPAND POST DEPLOYMENT. THE TARGET LESION WAS LOCATED IN THE VEIN. A 75CM WALLSTENT UNI WAS SELECTED FOR USE HOWEVER IT WAS NOTED THAT THE DEVICE WAS NOT ABLE TO FULLY EXPAND POST DEPLOYMENT. ANOTHER WALLSTENT WAS IMPLANTED TO TREAT THE UNDER EXPANDED STENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803451 ↗
• MalfunctionFeb 28, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURED. A 18X90MM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE FOR A STENTING PROCEDURE IN THE LEFT ILIAC VEIN. WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE STENT, THE STENT COLLAPSED ON ITSELF. THE PHYSICIAN THEN HAD TO USE A 16X90MM WALLSTENT ENDOPROSTHESIS, HOWEVER, THE SAME ISSUE BEGAN TO OCCUR WHEN THE PHYSICIAN ATTEMPTED DEPLOYMENT. THE STENT WAS RETRACTED AND REMOVED. ANOTHER 16X90MM WALLSTENT ENDOPROSTHESIS WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8379198 ↗
• MalfunctionFeb 11, 2019Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-JAN-2019. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED LEFT ILIAC VEIN. A 16X90/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED TO TREAT THE LESION; HOWEVER, THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT HARM NOR COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOWEVER, DEVICE ANALYSIS REVEALED DAMAGE TO DISTAL STENT WIRES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8326285 ↗