WALLSTENT® Endoprosthesis H965404130Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729204084), received between Dec 3, 2018 and Mar 7, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem; Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INNER PACKAGE LEAKED AIR. THE STENOSED TARGET LESION WAS LOCATED IN THE COMMON BILE DUCT. A 18X90 WALLSTENT SELF-EXPANDING WAS SELECTED FOR USE. DURING PREPARATION, UPON OPENING THE PACKAGE, IT WAS OBSERVED THAT THE INNER PACKAGING HAD AN AIR LEAK, RESULTING IN A COMPROMISE OF THE DEVICE'S STERILITY. THE PROCEDURE WAS COMPLETED USING 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 21552566 ↗
• InjuryJul 19, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY POSITIONING THE STENT WHICH REQUIRED PLACEMENT OF AN ADDITIONAL STENT. THE 90% STENOSED, AROUND 16MM TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 18X90/10FR 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED AND PLACED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THERE WAS DIFFICULTY POSITIONING THE STENT DURING PLACEMENT. THE DEPLOYED STENT DID NOT COVER THE ENTIRE LESION. AN ADDITIONAL STENT WAS PLACED TO COVER THE ENTIRE LESION. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17355608 ↗
• MalfunctionNov 18, 2020Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30OCT2020. IT WAS REPORTED THAT STENT DEPLOYMENT FAILURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ILIAC VEIN. A 18X90/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS NOT DEPLOYING PROPERLY, SO THE PHYSICIAN RE-CONSTRAINED THE DEVICE AND REMOVED IT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED NOR INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10860281 ↗
• MalfunctionOct 13, 2020Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC VEIN. A 18X90/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT WAS UNABLE TO CROSS OVER THE WIRE ONCE INSERTED INTO THE SHEATH. THE STENT WAS SUCCESSFULLY REMOVED FROM THE SHEATH UNDEPLOYED AND IT WAS NOTICED THAT THE TIP OF THE STENT HAD BEEN PUSHED BACK INTO THE STENT CATHETER AND THE SHAFT WAS BENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10672071 ↗
• MalfunctionJun 5, 2019Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AN 18X90/10FR WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE STENT FAILED TO EXPAND. THE DEVICE WAS REMOVED AND IT WAS THOUGHT THAT THE DEVICE WAS UNRAVELED OR SOMETHING WAS PREVENTING PROPER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAD A SUCCESSFUL OUTCOME. IT WAS FURTHER REPORTED THAT THE 60-70% STENOSED, COMPRESSED MORPHOLOGICAL TARGET LESION WAS LOCATED IN A NON-CALCIFIED VEIN. DURING ADVANCING, THROUGH THE GREAT SAPHENOUS VEIN AND POPLITEAL ARTERY WHICH HAD SIGNIFICANT FIBROTIC TISSUE POST THROMBOTIC SYNDROME, SOME THROMBOTIC TISSUES WERE CAUGHT AT THE DISTAL END OF THE CATHETER AND DRAPED DOWN. DURING DEPLOYMENT, THE STENT WOULD NOT EXPAND NORMALLY. A WHITE-RIBBON LOOKING MATERIAL PROTRUDING FROM THE DISTAL TIP WAS NOTED AND NO STENT DEFORMATION. THE STENT WAS COMPLETELY RECONSTRAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671243 ↗
• MalfunctionApr 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. DURING PREPARATION OF A 18X90/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS, IT WAS NOTED THAT THE WHITE TIP AT THE END OF THE CATHETER WAS MISSING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8514567 ↗
• MalfunctionMar 27, 2019Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN COMMON ILIAC VEIN. A 18X90/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS CATHETER WAS SELECTED FOR USE. DURING DEPLOYMENT, THE STENT "BULKED" AND IT WOULD NOT DEPLOY CORRECTLY, SO THE STENT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT BUCKLED WHEN IT WENT INSIDE THE PATIENT AND STENT WOULDN'T COME OUT. IT WAS NOT DEPLOYED SO THEY JUST PULLED THE DELIVERY SYSTEM OUT AND THE DELIVERY SYSTEM WAS DISPOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8456305 ↗
• MalfunctionMar 5, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED.A 18X90/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE FOR A VENOUS COMPRESSION PROCEDURE. THE STENT WAS ADVANCED OVER A .035 NON-BSC GUIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT MOVED DOWN SIGNIFICANTLY. AN ATTEMPT TO RE-SHEATH THE STENT WAS MADE BEFORE THE STENT REACHED THE SECOND MARKER, BUT THE STENT BUCKLED AND WAS NO LONGER THE SAME LENGTH. THE PHYSICIAN THEN REMOVED THE WHOLE SYSTEM FROM THE BODY AND SAW THAT THE DISTAL END WAS KINKED. ANOTHER 18X90/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE, HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A LARGER STENT AND DEPLOYMENT WAS STARTED HIGHER, WHICH WAS DONE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8390477 ↗
• MalfunctionMar 5, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED.A 18X90/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE FOR A VENOUS COMPRESSION PROCEDURE. THE STENT WAS ADVANCED OVER A .035 NON-BSC GUIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT MOVED DOWN SIGNIFICANTLY. AN ATTEMPT TO RE-SHEATH THE STENT WAS MADE BEFORE THE STENT REACHED THE SECOND MARKER, BUT THE STENT BUCKLED AND WAS NO LONGER THE SAME LENGTH. THE PHYSICIAN THEN REMOVED THE WHOLE SYSTEM FROM THE BODY AND SAW THAT THE DISTAL END WAS KINKED. ANOTHER 18X90/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE, HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A LARGER STENT AND DEPLOYMENT WAS STARTED HIGHER, WHICH WAS DONE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8390476 ↗
• InjuryFeb 28, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 18X90MM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE FOR A STENTING PROCEDURE IN THE LEFT ILIAC VEIN. WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE STENT, THE STENT COLLAPSED ON ITSELF. THE PHYSICIAN THEN HAD TO USE A 16X90MM WALLSTENT ENDOPROSTHESIS, HOWEVER, THE SAME ISSUE BEGAN TO OCCUR WHEN THE PHYSICIAN ATTEMPTED DEPLOYMENT. THE STENT WAS RETRACTED AND REMOVED. ANOTHER 16X90MM WALLSTENT ENDOPROSTHESIS WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8379197 ↗
• MalfunctionDec 3, 2018Failure to Capture; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Failure to Capture; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED RE-SHEATHING DIFFICULTIES OCCURRED. THE TARGET LESION LESION WAS LOCATED IN THE ILIAC ARTERY. A 18X90/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS USED FOR TREATMENT. WHEN THE PHYSICIAN DEPLOYED THE STENT THEY TRIED TO RETRIEVE TO CHANGE THE POSITION. HOWEVER, RE-SHEATHING DIFFICULTIES OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125738 ↗