WALLSTENT® Endoprosthesis H965405120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729204176), received between Nov 13, 2018 and Oct 19, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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.

• MalfunctionOct 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 75CM WALLSTENT UNI STENT SELF-EXPANDING WAS USED FOR AN ILIAC VEIN STENTING. HOWEVER, WHEN THE STENT WAS DEPLOYED AND FLOWERED, THEY NOTICED THAT THE TIP OF THE STENT DID NOT LOOK CORRECT AND APPEARED DISTORTED. ATTEMPTS WERE MADE TO REDEPLOY THE TIP OF THE STENT AND RECAPTURE IT, BUT STILL LOOKED THE SAME. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO INCIDENTS OR PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966840 ↗
• MalfunctionOct 1, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PREMATURELY DEPLOYED. THE TARGET LESION WAS LOCATED IN THE STENOSED PRECAVA. A 24X70/11FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT DEPLOYED IN THE POSTCAVA. THE PHYSICIAN TRIED TO SNARE THE STENT BUT FAILED. THE STENT WAS LEFT IN THE POSTCAVA AND THE PHYSICIAN PLANNED TO RE-ATTEMPT SNARING THE DEVICE OUT IN A COUPLE DAYS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9140978 ↗
• InjuryAug 27, 2019Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE INFERIOR VENA CAVA. A 24X70/11FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS DEPLOYED TO TREAT THE LESION. HOWEVER, THE DEPLOYED STENT MIGRATED APPROXIMATELY 1CM DISTAL. A NON-BSC BALLOON CATHETER WAS THEN INFLATED INTO THE STENT AND USED TO DRAG THE STENT DOWN INTO THE APPROPRIATE POSITION AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935949 ↗
• MalfunctionFeb 28, 2019Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURED. A WALLSTENT UNI WAS SELECTED FOR USE FOR A VENOUS COMPRESSION CASE. AFTER OPENING THE PACKAGE, THE INNER LINING RIPPED DOWN THE MIDDLE AND CONTAMINATED THE DEVICE STERILITY. THIS OCCURRED DURING PREPARATION, WHILE OUTSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8378460 ↗
• MalfunctionJan 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT DETACHMENT OCCURRED. DURING PREPARATION OF A 24X70/11FR 75CM WALLSTENT UNI; HOWEVER, UPON PLACING THE DEVICE INTO THE SHEATH, THE SHAFT APPEAR TO BE SEPARATED AND WOULD NOT DEPLOY PROPERLY. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8209663 ↗
• MalfunctionNov 13, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT WAS INADVERTENTLY DEPLOYED . THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 24X70/11FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. WHEN THE STENT WAS FLUSHED DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE STENT WAS EXPOSED. THE DEVICE WAS REPLACED WITH ANOTHER STENT WHICH WAS PLACED SUCCESSFULLY. FOLLOWING STENT IMPLANTATION, AN 18-4/5.8/75 XXL ESOPHAGEAL BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 5 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 8065345 ↗