WALLSTENT® Endoprosthesis H965402110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729203957), received between Jul 25, 2019 and Jan 21, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CENTRAL VEIN. A 2X40/8FR UNI PLUS HALO 75CM WALLSTENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT COULD NOT BE DEPLOYED EVEN WHEN THE DELIVERY SHAFT WAS PUSHED TO THE MAXIMUM. THE PROCEDURE WAS CANCELLED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13319644 ↗
• InjuryJul 25, 2019Difficult or Delayed Positioning; Positioning Problem; Migration; Difficult or Delayed Positioning; Positioning Problem; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 12X40/8FR/75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THERE WAS DIFFICULTY IN DEPLOYING THE STENT AND WHEN THE STENT WAS EVENTUALLY DEPLOYED, THE STENT MOVED AWAY FROM THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826687 ↗