WALLSTENT™ RP Endoprosthesis M001711260Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729406372), received between Dec 14, 2018 and Sep 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

• InjurySep 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT A STENT PROFILE PROBLEM OCCURRED. THE TARGET LESION WAS LOCATED IN THE BILE DUCT. AN 8X40X75/ 6F WALLSTENT RP ENDOPROSTHESIS WAS SELECTED FOR STENT IMPLANTATION. HOWEVER, AFTER STENTING, IT WAS NOTED THAT THE STENT SHORTENED BY NEARLY 50% AND DID NOT COMPLETELY COVER THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287277 ↗
• MalfunctionOct 29, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT STENT DIFFICULTY TO RECONSTRAIN WAS ENCOUNTERED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS VESSEL IN THE BILE DUCT. A 8X40X75/ 6F WALLSTENT RP ENDOPROSTHESIS STENT WAS USED TO CONTINUE THE PROCEDURE. THE PHYSICIAN POSITIONED AND ADJUSTED THE STENT BEFORE IT WAS RELEASED TO THE NON-RETRIEVABLE MARKER; HOWEVER, IT WAS FOUND THAT THE STENT NEEDED TO BE CONSTRAINED AND ADJUSTED AGAIN. WHEN THE STENT WAS CONSTRAINED, THE RESISTANCE WAS SO GREAT THAT IT COULD NOT BE CONSTRAINED AT ALL, THEN THE STENT WAS RELEASED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251001 ↗
• MalfunctionDec 14, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS DEFORMED. A UNISTEP PLUS WALLSTENT WAS SELECTED FOR USE FOR A BILIARY TRACT STENT IMPLANTATION IN THE BILE DUCTS. THE STENT REACHED THE LESION AND DEPLOYED FOR ABOUT 1CM WHEN THE PHYSICIAN NOTICED THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THE STENT WAS FULLY RECONSTRAINED WHEN REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8165068 ↗