WALLSTENT® Endoprosthesis H965404320Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729204114), received between Nov 21, 2018 and Mar 8, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TWO STENTS WERE COMPRESSED, AND AN ADDITIONAL PROCEDURE WAS PERFORMED WITH THE INTENTION TO OPEN THEM. TWO WALLSTENT ENDOPROSTHESIS STENTS WERE SELECTED FOR USE AND WERE IMPLANTED. OVER FIVE YEARS LATER, THE PATIENT UNDERWENT A MEDICAL INTERVENTION TO OPEN THE STENTS. THE PHYSICIAN NOTED THAT THE STENTS WERE FULLY INCORPORATED INTO THE VEIN WALL, AND A WIRE WAS UNABLE TO CROSS INTO THE INFERIOR VENA CAVA FROM THE RIGHT COMMON ILIAC VEIN. ADDITIONALLY, THE RIGHT ILIAC STENT WAS BEING COMPRESSED BY THE LEFT ILIAC STENT. THE PATIENT WAS INFORMED BY THE PHYSICIAN THAT A THIRD PHYSICIAN WOULD NEED TO BE CONSULTED FOR FURTHER TREATMENT OPTIONS. THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504599 ↗
• InjuryMar 8, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TWO STENTS WERE COMPRESSED, AND AN ADDITIONAL PROCEDURE WAS PERFORMED WITH THE INTENTION TO OPEN THEM. TWO WALLSTENT ENDOPROSTHESIS STENTS WERE SELECTED FOR USE AND WERE IMPLANTED. OVER FIVE YEARS LATER, THE PATIENT UNDERWENT A MEDICAL INTERVENTION TO OPEN THE STENTS. THE PHYSICIAN NOTED THAT THE STENTS WERE FULLY INCORPORATED INTO THE VEIN WALL, AND A WIRE WAS UNABLE TO CROSS INTO THE INFERIOR VENA CAVA FROM THE RIGHT COMMON ILIAC VEIN. ADDITIONALLY, THE RIGHT ILIAC STENT WAS BEING COMPRESSED BY THE LEFT ILIAC STENT. THE PATIENT WAS INFORMED BY THE PHYSICIAN THAT A THIRD PHYSICIAN WOULD NEED TO BE CONSULTED FOR FURTHER TREATMENT OPTIONS. THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504598 ↗
• InjuryJun 10, 2021Difficult or Delayed Positioning; Defective Device; Difficult or Delayed Positioning; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED PROXIMAL LEFT COMMON ILIAC VEIN (CIV). A 20X80/10FR UNI PLUS 75CM WALLSTENT UNI STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THERE WAS DIFFICULTY DEPLOYING THE STENT. THE STENT KEPT DROPPING NEAR FINAL DEPLOYMENT SO IT HAD TO BE RECAPTURED TWICE. THE STENT WAS SUCCESSFULLY IMPLANTED; HOWEVER, IT FORESHORTENED NEAR THE CIV SO AN ADDITIONAL PROXIMAL STENT WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977500 ↗
• MalfunctionFeb 14, 2020Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 20X80/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR USE. HOWEVER, DURING DEPLOYMENT, THE STENT WOULD NOT DEPLOY AND IT WAS NOTED THAT THE STENT STRUTS WERE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9711258 ↗
• InjuryJan 2, 2020Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC VEIN. A 20X80/10FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS DEPLOYED TO TREAT THE LESION. A NON-BSC BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION; HOWEVER, WHEN THE BALLOON WAS PLACED INSIDE THE STENT, THE STENT MOVED INTO THE INFERIOR VENA CAVA. A 20X55 WALLSTENT WAS THEN USED TO PIN THE MIGRATED STENT TO THE VESSEL WALL AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538750 ↗
• InjuryNov 21, 2018Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. A 20X80/10FR 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. THE STENT WAS PLACED AND IT APPEARED TO BE POSITIONED CORRECTLY. THE PHYSICIAN THEN POST-DILATED THE SENT WITH AN UNSPECIFIED 20MM BALLOON CATHETER AT THE PROXIMAL END OF THE STENT. HOWEVER, WHEN THE BALLOON WAS DEFLATED AFTER POST-DILATION, THE STENT MOVED PROXIMALLY FOR AN UNKNOWN REASON. IT ENDED UP BEING IN A LOCATION THAT WAS A LITTLE BIT HIGHER THAN THEY WANTED IT. ADDITIONAL WALLSTENT DEVICES WERE IMPLANTED TO COVER THE COMPRESSED AREAS. EVEN WITHOUT THE ISSUE WITH THE MIGRATION ADDITIONAL STENTS WOULD HAVE LIKELY BEEN NEEDED ANYWAYS. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8095374 ↗