WALLSTENT® Endoprosthesis H965404120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729204077), received between Mar 13, 2020 and May 20, 2021 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionMay 20, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT POSITIONING PROBLEMS WERE ENCOUNTERED. THE 60-80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED INFERIOR VENA CAVA (IVC). A 75CM 18X60/10FR UNI PLUS WALLSTENT ENDOPROSTHESIS WAS ADVANCED; HOWEVER, THE DEVICE JUMPED TO DIFFERENT LOCATION THAN THE PHYSICIAN WAS MEANT TO DEPLOY FROM THE IVC TO THE RENAL VEIN. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855914 ↗
• MalfunctionSep 2, 2020Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED AND THE PROCEDURE WAS CANCELLED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT COMMON ILIAC VEIN. A 18X60/10FR UNI PLUS 75CM WAS ADVANCED THROUGH A 13FR NON-BSC SHEATH TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT, THE DISTAL END OF THE STENT WOULD NOT OPEN ON MULTIPLE ATTEMPTS. THE DEVICE WAS RECAPTURED AND WAS COMPLETELY REMOVED OUTSIDE THE PATIENT'S BODY. THE PHYSICIAN ATTEMPTED TO DEPLOY ON THE TABLE BUT THE STENT WOULD STILL NOT OPEN AND IT WAS NOTICED THAT THE EDGES WERE MANGLED. NO REPLACEMENT STENTS WERE AVAILABLE SO THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482382 ↗
• InjuryMar 13, 2020Adverse 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 18X60 10FR 75CM WALLSTENT ENDOPROSTHESIS WAS PLACED IN THE PATIENT. THE PATIENT EXPERIENCED AN ALLERGIC REACTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9829612 ↗