WALLSTENT® Endoprosthesis H965404310Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729204107), received between Jan 30, 2020 and Jan 25, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJan 25, 2023Positioning Failure; Mechanical Problem; Positioning Failure; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE WAS REMOVED NOT FULLY CONSTRAINED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED BRONCHIAL ARTERY. A 20X55/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS NOT FULLY CONSTRAINED WHEN REMOVED AND THE TIP WAS OUTSIDE THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240330 ↗
• MalfunctionSep 7, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 20X55/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE STENT WAS KINKED WHEN IT CAME OUT FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10499525 ↗
• MalfunctionJan 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING UNPACKING OF A 20X55/10FR UNI PLUS 75CM WALLSTENT, IT WAS NOTED THAT THE STENT DEPLOYMENT TIP WAS MISSING WHILE THE DISTAL RADIOPAQUE MARKER BAND WAS STILL INTACT. UPON FURTHER INSPECTION, THE MISSING TIP WAS NOT IN THE PACKING EITHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALL STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9646749 ↗