WALLSTENT® Endoprosthesis H965402120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729203964), received between Mar 29, 2019 and Sep 1, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2023Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT UNDERWENT STENT IMPLANTATION. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 12X60/8FR 75CM WALLSTENT UNI (WALLSTENT ENDOPROSTHESIS). HOWEVER, UPON UNPACKING, IT WAS NOTICED THAT THERE WAS A CREASE AT THE MIDDLE PORTION OF THE STENT. IT COULD NOT BE DEPLOY AND WAS REMOVED COMPLETELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672880 ↗
• InjuryMay 19, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT POSITIONING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A VEIN. FOLLOWING THROMBECTOMY WITH AN ANGIOJET AND PRE-DILATATION WITH A CHARGER BALLOON CATHETER, A 12X60/8FR 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED BUT COULD NOT BE DEPLOYED. THE PHYSICIAN TRIED SEVERAL TIMES, BUT THE STENT COULD NOT BE POSITIONED ACCURATELY. INSTEAD, THE PHYSICIAN DEPLOYED THE STENT IN SITU. THE STENT WAS NOT ABLE TO COVER THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 12X60 WALLSTENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10069621 ↗
• InjuryNov 25, 2019Difficult or Delayed Activation; Positioning Problem; Difficult or Delayed Activation; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS DEPLOYED IN AN UNINTENDED PLACE. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 75 CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THERE WAS DIFFICULTY DEPLOYING THE STENT. WHEN THE PHYSICIAN DEPLOYED THE STENT, THE STENT WAS DEPLOYED IN UNINTENDED LOCATION. A SECOND STENT WAS THEN DEPLOYED TO TREAT THE INTENDED LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369143 ↗
• InjuryMar 29, 2019Retraction Problem; Activation, Positioning or Separation Problem; Positioning Problem; Retraction Problem; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED THAT THE STENT DISLODGED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE PRECAVAL. A 75CM WALLSTENT ENDOPROSTHESIS STENT WAS INSERTED. THE STENT WAS SLOWLY RELEASED AT THE LESION SITE, HOWEVER, THE POSITION WAS NOT IDEAL. THE PHYSICIAN WITHDREW THE DEVICE, AND AFTERWARDS THE STENT DISLODGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTER REPORTED THAT THE STENT DEPLOYED WHEN THE PHYSICIAN TRIED TO RECONSTRAIN IT. THE STENT DEPLOYED IN AN UNIDEAL POSITION AND RECONSTRAINMENT OF THE DEVICE FAILED. THE DEVICE HAD TO BE REMOVED BY A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465449 ↗