WALLSTENT™ RP Endoprosthesis M001712320Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729345862), received between Aug 21, 2017 and Apr 6, 2018 — classified as 1 injury, 1 malfunction.

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

• MalfunctionApr 6, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 10X20X75MM WALLSTENT¿ RP ENDOPROSTHESIS WAS DEPLOYED TO THE LESION. HOWEVER, A NON-BSC GUIDE WIRE BECAME STUCK WITH THE GUIDE WIRE LUMEN. THE GUIDE WIRE WAS REMOVED AND A "YELLOW OBJECT" PART OF THE WALL WAS NOTED STICKING TO THE GUIDE WIRE. THE DEVICE COULD NOT BE RETRIEVED DUE TO INFECTIOUS DISEASE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7403861 ↗
• InjuryAug 21, 2017Bent; Bent

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS CEPHALIC VEIN. A 10X20X75 WALLSTENT¿ RP ENDOPROSTHESIS WAS SUCCESSFULLY DEPLOYED HOWEVER; IT WAS NOTED THAT THE STENT HAD FORESHORTENED. A 8X38 WALLSTENT¿ RP ENDOPROSTHESIS WAS DEPLOYED TO FULLY COVER THE LESION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6807944 ↗