WALLSTENT® Endoprosthesis H965403320Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729204046), received between Dec 2, 2019 and Jan 29, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Activation, Positioning or Separation Problem; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16X60/9FR UNI PLUS 75CM WALLSTENT UNI STENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT, AND ADVANCEMENT WAS NOT SMOOTH. AFTER REACHING THE LESION LOCATION, THE SHAFT WAS PULLED TO DEPLOY THE STENT; HOWEVER, THE STENT DID NOT RESPOND. RESISTANCE OCCURRED WHEN APPROXIMATELY ONE THIRD OF THE STENT HAD BEEN DEPLOYED. THE STENT WAS WITHDRAWN ALONG THE GUIDEWIRE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.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 24210405 ↗
• MalfunctionSep 5, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED LOCATED IN THE NON-TORTUOUS LEFT ILIAC VEIN. A 75CM WALLSTENT UNI CATHETER WAS USED FOR TREATMENT. HOWEVER, UPON UNPACKING, IT WAS NOTED THAT THERE WAS A CREASE AT THE TIP OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152847 ↗
• MalfunctionJun 18, 2024Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. ROUTINE A 16X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE ANGIOGRAPHY REVEALED THAT THE PROXIMAL OPENING OF THE LEFT VEIN WAS BLOCKED. DUE TO THE BLOCKAGE IN THE MIDDLE AND LONG SEGMENT OF THE RIGHT ILIAC VEIN, BALLOON DILATION AND STENT PLACEMENT WAS PERFORMED LATER. THE VENOUS STENT WITH ITS DELIVERY SYSTEM WAS STUCK AND ONLY ABOUT 30% OF THE DEVICE DEPLOYED WHEN THE STENT WAS INSERTED INTO THE PROXIMAL SEGMENT OF THE LEFT ILIAC VEIN. WHEN THE STENT WAS WITHDRAWN, IT NEEDED TO BE PULLED BACK WITH FORCE INTO THE SHEATH AND RESTRAINED. THE ENTIRE SYSTEM WAS WITHDRAWN. IT WAS FOUND THERE WAS A KINK MARK ABOUT 4CM FROM THE TIP OF THE STENT, RESULTING IN UNABLE TO DEPLOY NORMALLY. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559770 ↗
• InjuryJul 14, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN ILIAC VEIN. A 16X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, POST DEPLOYMENT, THE STENT MIGRATED TO THE ATRIUM. THE DEVICE WAS FORCIBLY REMOVED USING A FORCEPS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014708 ↗
• InjuryNov 11, 2020Migration; Migration

  IT WAS REPORTED THAT THE STENT MIGRATED. AN 18X90X75CM VENOUS WALLSTENT WAS SELECTED AND 16X60X75CM WALLSTENT ENDOPROSTHESIS WERE SELECTED FOR USE WITHIN THE RIGHT COMMON ILIAC VEIN AND EXTERNAL ILIAC VEIN. THE LESION WAS 50% STENOSED, NON-CALCIFIED, AND NON-TORTUOUS. THE VENOUS WALLSTENT WAS PLACED IN THE RIGHT 15.5MM DIAMETER COMMON ILIAC VEIN AND THE WALLSTENT ENDOPROSTHESIS WAS OVERLAPPED APPROXIMATELY 2CM INTO THE 14MM DIAMETER VESSEL EXTENDING INTO THE RIGHT EXTERNAL ILIAC VEIN. POST DILATION WAS PERFORMED. THE STENTS WERE FULLY APPOSED. AFTER, THE VENOUS WALLSTENT MIGRATED INTO THE INFERIOR VENA CAVA (IVC) AND THE WALLSTENT ENDOPROSTHESIS MIGRATED SLIGHTLY AS WELL. DUE TO THE MIGRATION, ANOTHER 18X90 WALLSTENT WAS PLACED BETWEEN THE INITIAL TWO IMPLANTED STENTS. NO ADDITIONAL MIGRATION WAS OBSERVED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10826057 ↗
• InjuryJul 2, 2020Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. A 16X60/9FR WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT JUMPED A LOT AFTER DEPLOYMENT. ANOTHER STENT WAS USED TO COMPLETED THE CASE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Code Available

  MAUDE report 10224671 ↗
• InjuryApr 29, 2020Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. A 16X60/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT; HOWEVER, THE STENT MIGRATED POST DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LEFT EXTERNAL ILIAC VEIN WITH 60% STENOSIS. THE VESSEL DIAMETER MEASURED 16MM IN THE COMMON ILIAC VEIN AND RANGED DOWN TO 13MM IN THE EXTERNAL VEIN SEGMENT. WHEN THE STENT WAS IMPLANTED, IT FORESHORTENED DISTALLY AND WAS NOT ABLE TO COMPLETELY COVER THE STENOSIS IN THE DISTAL EXTERNAL ILIAC VEIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009676 ↗
• InjuryMar 24, 2020Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED AND REQUIRED ADDITIONAL INTERVENTION. ON (B)(6) 2020, THE MORE THAN 75% STENOSED TARGET LESION, MEASURING 15MM IN HEALTHY VESSEL, WAS LOCATED IN THE RIGHT SUBCLAVIAN VEIN AND NOTED VIA IVUS. DURING THE PROCEDURE, A 16MM X 60MM X 75CM WALLSTENT ENDOPROSTHESIS STENT WAS DEPLOYED. THE STENT WAS PRE AND POST DILATED WITH CHARGER BALLOON DILATATION CATHETERS 8MM X 40MM AND 10 MM X 40MM. THE PHYSICIAN WAS PLEASED WITH THE RESULTS AND THE PATIENT OUTCOME WAS OPTIMAL. ON (B)(6) 2020, IT WAS NOTED THAT THE WALLSTENT HAD MIGRATED TO THE SUPERIOR VENA CAVA, PAST THE INITIAL STENOSIS AND PLACEMENT BY AT LEAST 2-3 CM. A 16MM X 60MM VICI VENOUS STENT WAS PLACED AT THE LESION. POST DILATATION WAS COMPLETED WITH A BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE AND DOING WELL POST PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9871793 ↗
• MalfunctionJan 29, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE STENT WAS SHORTER THAN THE LABELED SIZE. A 16X60/9FR UNI PLUS 75CM WALLSTENT-UNI ENDOPROSTHESIS SELF EXPANDING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT IN THE DELIVERY SYSTEM WAS SHORTER THAN IT SHOULD BE. THE STENT WAS NOT DEPLOYED AND WAS PULLED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642555 ↗
• InjuryDec 2, 2019Premature Activation; Retraction Problem; Premature Activation; Retraction Problem

  IT WAS REPORTED THAT RECONSTRAINMENT DIFFICULTIES OCCURRED. THE TARGET LESION WA LOCATED IN THE RIGHT COMMON ILIAC VEIN. A 16X60/9FR WALLSTENT UNI WAS ADVANCED FOR TREATMENT ALONG WITH A 18X90 WALLSTENT IN AN ATTEMPT TO BARREL BOTH STENTS INTO THE INFERIOR VENA CAVA (IVC). HOWEVER, IT WAS NOTED THAT 20% OF THE 16X60 STENT WAS DEPLOYED IN THE IVC. WHILE ATTEMPTING TO RECAPTURE THE STENT FOR REPOSITIONING, THE STENT FULLY DEPLOYED. ANOTHER 18X90MM WALLSTENT WAS DEPLOYED INSIDE THE STENT AND INFLATED WITH A 16X40MM XXL BALLOON CATHETER ON BOTH SIDES. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS FINE AND STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395936 ↗