WALLSTENT™ RP Endoprosthesis M001711280Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729406396), received between Sep 6, 2019 and May 8, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Premature Activation; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. THE PATIENT HAD BILIARY STENOSIS AND UNDERWENT BALLOON DILATATION WITH STENT IMPLANTATION. AN 8X60X75 MM / 6F WALLSTENT REDUCED PROFILE SELF-EXPANDING STENT WAS SELECTED FOR THE TREATMENT. DURING THE PROCEDURE, A 6F PUNCTURE SHEATH AND A 0.035 X 260 CM GUIDEWIRE WERE USED TO CROSS THE LESION. HOWEVER, THE STENT COULD NOT CROSS SMOOTHLY THROUGH THE Y-VALVE AND WAS ACCIDENTALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987867 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH PANCREATIC SPACE OCCUPYING LESION, OBSTRUCTIVE JAUNDICE, AND HYPERTENSION. THE TARGET LESION WAS LOCATED IN THE BILIARY TRACT. THE PATIENT WAS PLACED IN A SUPINE POSITION FOR PERCUTANEOUS STENT IMPLANTATION. AFTER PLACING AN 035 GUIDEWIRE AND A 6F-LONG SHEATH, AN 8X60X75/ 6F WALLSTENT RP ENDOPROSTHESIS WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS FOUND THAT THE PROTECTIVE SHEATH OF THE STENT WAS FRACTURED. THE DEVICE WAS REPLACED WITH ANOTHER OF SAME DEVICE, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053232 ↗
• MalfunctionJan 16, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19DEC2023. IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO POSITION. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE BILIARY TRACT. THE PATIENT SHOWED SPACE OCCUPYING LESION OF PANCREAS, PANCREATIC CANCER, OBSTRUCTIVE JAUNDICE, HYPERTENSION. PERCUTANEOUS BILIARY STENT IMPLANTATION WAS PERFORMED AS THEY WERE IN A SUPINE POSITION. A 0.035 NON-BSC GUIDEWIRE AND 6F LONG SHEATH WERE SELECTED FOR THE PROCEDURE AND A 8X60X75/ 6F REDUCED PROFILE WALLSTENT WAS ADVANCED FOR IMPLANTING. WHEN THE STENT REACHED AN UNRECOVERABLE POINT, IT WAS STUCK AND COULD NOT DEPLOY. THE STENT FULLY RECONSTRAINED BY SHEATH, AND THE GUIDEWIRE AND STENT SYSTEM WERE REMOVED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE COMPLICATIONS REPORTED AND THE PATIENT WAS IN A STABLE CONDITION. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE STENT FULLY DEPLOYED FROM THE DELIVERY SYSTEM. STENT DAMAGE AND SHEATH KINKING/ACCORDION DAMAGE WAS ALSO NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521897 ↗
• MalfunctionNov 23, 2022Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT AND SHAFT DAMAGE OCCURRED. THE TARGET LESION WAS SEVERELY STENOSED. A 8X60X75/ 6F WALLSTENT RP ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT COULD NOT BE PUSH WHEN PUSHED FOR A HALF. AFTER SEVERAL ATTEMPTS, THE SHEATH WAS NOTED TO BE WRINKLED AFTER REMOVAL. THE DEVICE WAS REMOVED FULLY RECONSTRAINED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED AND WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852502 ↗
• MalfunctionMay 31, 2022Positioning Failure; Mechanical Problem; Positioning Failure; Mechanical Problem

  IT WAS REPORTED THAT THE STENT WAS NOT FULLY RECONSTRAINED. THE STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED BILIARY TRACT. PRE-DILATATION WAS PERFORMED AND A 8X60X75/ 6F WALLSTENT RP ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. DURING THE STENT IMPLANTATION PROCESS, THE STENT DELIVERY SHAFT HAD BEEN ADVANCED TO THE END, HOWEVER, THE STENT WAS NOT DEPLOYED ALTHOUGH THE PHYSICIAN TRIED TO DEPLOY IT THREE TIMES. THE STENT WAS NOT ABLE TO BE FULLY RECONSTRAINED WHEN REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14552292 ↗
• MalfunctionMar 10, 2022Break; Premature Activation; Difficult to Advance; Break; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT SHEATH BREAK OCCURRED. AN 8X60X75/ 6F UNISTEP PLUS WALLSTENT RP ENDOPROSTHESIS WAS SELECTED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS LOADED IN THE GUIDEWIRE, IT WOULD NOT ADVANCED. THE STENT CAME OUT AND THE SHEATH BROKE WHEN THE DEVICE WAS PULLED BACK. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727415 ↗
• MalfunctionMar 6, 2020Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21FEB2020 IT WAS REPORTED THAT ADVANCING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE BILIARY TRACT. A 8X60X75/ 6F REDUCED PROFILE WALLSTENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT COULD NOT BE ADVANCED AFTER ADVANCING A SMALL PART. THE PHYSICIAN TRIED SEVERAL TIMES BUT IT WAS STILL UNABLE TO BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE STENT WAS PARTIALLY FLARED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799985 ↗
• MalfunctionDec 9, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE BILE DUCT. A 8X60X75/ 6F WALLSTENT RP ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT BE DETACHED FROM A NON-BSC GUIDE WIRE. BOTH DEVICES WERE REMOVED FROM PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440552 ↗
• MalfunctionSep 6, 2019Retraction Problem; Activation, Positioning or Separation Problem; Retraction Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED AND THE DEVICE WAS REMOVED WITHOUT RECONSTRAINING. THE 50-60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED TRANSHEPATIC BILIARY. A 8X60X75//6F WALLSTENT RP ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER THE STENT SHEATH REACHED THE TARGET POSITION, THE STENT COULD NOT FULLY DEPLOY. THE STENT WAS NOT FULLY RECONSTRAINED BACK INTO THE CATHETER. THE DEVICE WAS SIMPLY PULLED BACK AND REMOVED. 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 8971200 ↗