WALLSTENT RP EndoprosthesisRecalls & reported problems across all models

We found 19 models of WALLSTENT RP Endoprosthesis by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2017 and Jul 21, 2025 — classified as 8 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WALLSTENT RP Endoprosthesis problems

WALLSTENT RP Endoprosthesis models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WALLSTENT™ RP Endoprosthesis M001711280

  CATHETER, BILIARY, DIAGNOSTIC
  9 reports
• WALLSTENT™ RP Endoprosthesis M001711300

  CATHETER, BILIARY, DIAGNOSTIC
  5 reports
• WALLSTENT™ RP Endoprosthesis M001712180

  STENT, ILIAC
  3 reports
• WALLSTENT™ RP Endoprosthesis M001711260

  CATHETER, BILIARY, DIAGNOSTIC
  3 reports
• WALLSTENT™ RP Endoprosthesis M001712100

  STENT, ILIAC
  2 reports
• WALLSTENT™ RP Endoprosthesis M001712320

  STENT, ILIAC
  2 reports
• WALLSTENT™ RP Endoprosthesis M001712380

  STENT, ILIAC
  2 reports
• WALLSTENT™ RP Endoprosthesis M001712200

  STENT, ILIAC
  1 report
• WALLSTENT™ RP Endoprosthesis M001712000

  STENT, ILIAC
  1 report
• WALLSTENT™ RP Endoprosthesis M001712060

  STENT, ILIAC
  1 report
• WALLSTENT™ RP Endoprosthesis M001712220

  STENT, ILIAC
  1 report
• WALLSTENT™ RP Endoprosthesis M001712360

  STENT, ILIAC
  1 report
• WALLSTENT™ RP Endoprosthesis M001712390

  STENT, ILIAC
  1 report
• WALLSTENT™ RP Endoprosthesis M001711270

  Prosthesis, tracheal, expandable
  1 report
• WALLSTENT™ RP Endoprosthesis M001711290

  Prosthesis, tracheal, expandable
  1 report
• WALLSTENT™ RP Endoprosthesis M001711340

  STENT, CORONARY
  1 report
• WALLSTENT™ RP Endoprosthesis M001711350

  Prosthesis, tracheal, expandable
  1 report
• WALLSTENT™ RP Endoprosthesis M001711360

  SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
  1 report
• WALLSTENT™ RP Endoprosthesis M001711380

  STENT, CORONARY
  1 report

Recent WALLSTENT RP Endoprosthesis adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionMar 21, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS DEFORMED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PORTAL VESSEL. AN 8X60X135 WALLSTENT RP SELF-EXPANDING STENT WAS CHOSEN FOR THE PROCEDURE. DURING THE PROCEDURE, THE STENT WAS ADVANCED TO THE TARGET LESION SITE FOR DEPLOYMENT. HOWEVER, IT WAS DISCOVERED THAT THE STENT COULD NOT BE SUCCESSFULLY DEPLOYED. UPON RETRACTING THE STENT AND ITS DELIVERY SYSTEM, IT WAS OBSERVED THAT THE STENT HAD BECOME DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662291 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 19, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS SHUNT. A 10X94X75/ 7F WALLSTENT RP ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT, THE STENT HARDLY DEPLOYED INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771578 ↗
• MalfunctionFeb 20, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT POST TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT FOR THE TREATMENT OF LARGE VOLUME CLOT IN THE MAIN EXTRAHEPATIC PORTAL SUPERIOR MESENTERIC VEIN AND SPLENIC CONFLUENCE EXTENDING INTO THE RIGHT PORTAL VEIN. A 10X42X135/ 7F REDUCED PROFILE WALLSTENT RP ENDOPROSTHESIS WAS SELECTED TO TREAT THE LESION. HOWEVER, THE DEVICE WAS FOUND TO BE BROKEN PROXIMAL TO THE HUB. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404935 ↗
• 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 ↗
• MalfunctionJun 29, 2022Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09-JUN-2022. IT WAS REPORTED THAT STENT DEPLOYMENT ISSUES OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A THIN SHUNT OF THE FOREARM VEIN. A 4-40 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. A NON- BOSTON SCIENTIFIC BALLOON CATHETER WAS ADVANCED AND DILATATION WAS PERFORMED. SUBSEQUENTLY, A 6X24X75CM WALLSTENT RP ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE OUTER SHAFT WAS TOO HARD TO PULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER 7-23 WALLSTENT. THERE WERE NO PATIENT INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851834 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 28, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED SHUNT. A 6X59X75/ ILIAC 6F UNISTEP PLUS REDUCED PROFILE WALLSTENT WAS SELECTED FOR USE. HOWEVER, AFTER DEPLOYING THE STENT, THE SYSTEM WAS CAUGHT ON THE MOST BENT PART OF THE STENT AND COULD NOT BE REMOVED. IT WAS REPEATEDLY PUSHED AND PULLED FOR SEVERAL TIMES AND WAS REMOVED AFTER CHANGING THE ANGLE DIRECTLY ABOVE THE SKIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465461 ↗

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