VENOUS WALLSTENT™ H74912044186070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729979609), received between Jun 13, 2022 and Jul 25, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. AN 18X60X75CM VENOUS WALLSTENT SELF-EXPANDING STENT WAS ADVANCED AND PLACED FOR RE-INTERVENTION OF THE LEFT ILIAC VEIN. HOWEVER, WHEN THE IMPLANTED STENT WAS DILATED WITH A 18X6 XXL BALLOON CATHETER, THE STENT WAS FRACTURED AT THE PROXIMAL END. A NEW STENT WAS PLACED TO RELINE WITH THE FIRST PLACED STENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832570 ↗
• InjuryFeb 3, 2023Difficult to Advance; Positioning Problem; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO POSITION. THE PATIENT PRESENTED WITH MAY-THURNER SYNDROME AND UNDERWENT STENTING. THE 74% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED ILIAC VEIN. AN 18X60X75CM VENOUS WALLSTENT WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE WITH MUCH DIFFICULTY. THE STENT WAS DEPLOYED AND POST-DILATED WITH A 12MM CHARGER BALLOON WITH GOOD VESSEL APPOSITION. HOWEVER, THE PHYSICIAN WAS UNHAPPY WITH THE PLACEMENT OF THE STENT AND DECIDED TO DEPLOY A 18X90 VENOUS WALLSTENT TO ANCHOR AND REINFORCE THE PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN FELT THE STENT WAS MALDEPLOYED AND COMMENTED ON APPEARANCE OF WEBBING IN THE ILIAC VEIN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16295405 ↗
• InjurySep 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BALLOON BURST AND A FRAGMENT BECAME ENTRAPPED ON THE IMPLANTED STENTS. THE TARGET LESION WAS 65% STENOSED AND LOCATED IN THE ILIAC VEIN. TWO VENOUS WALLSTENTS WERE SUCCESSFULLY IMPLANTED TO TREAT MAY-THURNER SYNDROME. AN XXL BALLOON WAS SELECTED FOR USE TO POST-DILATE THE VENOUS WALLSTENTS. THE XXL BALLOON WAS INFLATED TWICE AT FIVE ATMOSPHERES FOR 30 SECOND DURATIONS. HOWEVER, THE BALLOON BURST AND A FRAGMENT BECAME CAUGHT ON THE IMPLANTED WALLSTENTS. THE PHYSICIAN ATTEMPTED TO USE A SNARE TO REMOVE THE FRAGMENT BUT WAS UNSUCCESSFUL. ANOTHER STENT WAS THEN IMPLANTED TO TRAP THE BALLOON FRAGMENT AGAINST THE IMPLANTED STENTS. A FUTURE PROCEDURE IS PLANNED IN ORDER TO REMOVE THE BALLOON FRAGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521029 ↗
• InjuryJun 13, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. A 18X60X75CM VENOUS WALLSTENT WAS SELECTED FOR THE INDEX PROCEDURE. THE STENT HAD BEEN THOUGHT TO BE DEPLOYED IN THE BODY; HOWEVER, THE STENT POPPED OUT OF THE DELIVERY SYSTEM. THE STENT WAS REPLACED WITH ANOTHER STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681153 ↗