WALLSTENT™ RP Endoprosthesis M001711300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729406419), received between Sep 25, 2017 and Jul 21, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Positioning Failure; Difficult to Advance; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Difficult to Advance; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL IN THE BILIARY TRACT. DURING THE PROCEDURE, IT WAS DIFFICULT TO PUSH THE STENT, AND THE PLASTIC SKIN OF THE STENT WAS FRACTURED. CONSEQUENTLY, THE STENT COULD NOT BE DEPLOYED THROUGH THE ADVANCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556037 ↗
• MalfunctionDec 20, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE BILE DUCT. AN 8X80X75/6F REDUCED PROFILE WALLSTENT WAS ADVANCED TO TREAT THE LESION, HOWEVER, THE STENT COULD NOT BE DELIVERED. AFTER SEVERAL FAILED ATTEMPTS, IT WAS NOTED THAT THE SHEATH WAS FOLDED. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365814 ↗
• MalfunctionNov 12, 2020Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-OCT-2020. IT WAS REPORTED THAT STENT DIFFICULTY ADVANCING WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE BILIARY TRACT. AN 8X80X75/ 6F WALLSTENT RP ENDOPROSTHESIS WAS USED, BUT COULD NOT BE ADVANCED AFTER ADVANCING A PART OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829581 ↗
• InjuryApr 24, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT STENT SIZE INCORRECT FOR THE LESION OCCURRED. A 8X80X75/ 6F WALLSTENT WAS ADVANCED TO TREAT THE LESION LOCATED IN THE BILE DUCT. HOWEVER, WHEN THE PHYSICIAN RELEASED THE STENT, IT WAS FOUND THAT THE LENGTH OF THE STENT WAS INCORRECT FOR THE LESION DETAILS. THE DEVICE WAS REMOVED WITH A SNARE AND 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 8544594 ↗
• MalfunctionSep 25, 2017Retraction Problem; Activation, Positioning or Separation Problem; Retraction Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT, RECONSTRAINMENT DIFFICULTY AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE BILIARY TRACT. AN 8X80X75/ 6F WALLSTENT¿ RP ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, AFTER THE LESION WAS FULLY COVERED, THE PHYSICIAN FOUND THE STENT WAS NOT FULLY DEPLOYED WITH PARTS OF THE STENT WAS STILL IN THE SHEATH. THE PHYSICIAN DECIDED TO REMOVE THE STENT OUT OF THE PATIENT AND TRIED TO SLIGHTLY WITHDRAW THE STAINLESS STEEL TUBE IN ORDER TO RECONSTRAIN THE STENT, BUT FAILED. THE PHYSICIAN THEN CAREFULLY REMOVED THE STENT WITH NEARLY 80MM STENT WAS OUT OF THE SHEATH. AFTER THE STENT WAS REMOVED OUT OF THE PATIENT, THE LENGTH OF THE STENT WAS MEASURED WITH 90MM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6892050 ↗