VENOUS WALLSTENT™ H74912044169070Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729979586), received between May 28, 2021 and Feb 26, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT STENT DIFFICULT TO DEPLOY REQUIRING INTERVENTION. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MILD CALCIFIED VESSEL. A 16X90X75CM VENOUS WALLSTENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS A SLIGHT HESITATION WITH FULL RELEASE OF THE STENT OFF THE DELIVERY SYSTEM UNTIL THE STENT WAS FULLY RELEASED AND ADDITIONAL STENT WAS USED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT REMOVED AND THERE WERE TWO STENTS USED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN, AND THE USE OF THE SECOND STENT IN THE PROCEDURE WAS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464135 ↗
• InjuryJan 5, 2026Difficult or Delayed Activation; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED WHICH REQUIRED AN ADDITIONAL STENT. A 16 X 90 X 75 CM VENOUS WALLSTENT WAS ADVANCED FOR TREATMENT. DURING DEPLOYMENT, THE STENT APPEARED TO STICK TO THE DELIVERY SYSTEM, RESULTING IN SLIGHT MIGRATION. A SECOND VENOUS WALLSTENT WAS SELECTED FOR USE. DURING DEPLOYMENT, THE STENT WAS FOUND TO BE STICKING TO THE DELIVERY SYSTEM SHAFT, CAUSING A DELAY IN FULLY COMING OFF AND EXPANDING. THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS, NON-CALCIFIED VESSEL, AND THAT NO RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. ALL STEPS WERE NOTED TO HAVE PROCEEDED NORMALLY UP TO THE PROXIMAL END OF THE STENT. IT WAS REPORTED THAT ALL OF THE STENTS HAD BEEN DEPLOYED EXCEPT FOR THE PROXIMAL END LOCATED BETWEEN THE TWO MARKER BANDS. DEPLOYMENT OF EACH STENT WAS COMPLETED, WITHIN APPROXIMATELY 1-2 SECONDS. NO ADDITIONAL MANEUVERS WERE REQUIRED DURING DEPLOYMENT OTHER THAN A BRIEF WAIT BEFORE THE DELIVERY SYSTEM WAS MOVED. FOLLOWING RELEASE, THE PROCEDURE WAS REPORTED TO HAVE PROCEEDED NORMALLY, AND THE DELIVERY SYST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962247 ↗
• MalfunctionJan 5, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED WHICH REQUIRED AN ADDITIONAL STENT. A 16X90X75 CM VENOUS WALLSTENT WAS ADVANCED FOR TREATMENT. DURING DEPLOYMENT, THE STENT APPEARED TO STICK TO THE DELIVERY SYSTEM, RESULTING IN SLIGHT MIGRATION. A SECOND VENOUS WALLSTENT WAS SELECTED FOR USE. DURING DEPLOYMENT, THE STENT WAS FOUND TO BE STICKING TO THE DELIVERY SYSTEM SHAFT, CAUSING A DELAY IN FULLY COMING OFF AND EXPANDING. THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS, NON-CALCIFIED VESSEL, AND THAT NO RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. ALL STEPS WERE NOTED TO HAVE PROCEEDED NORMALLY UP TO THE PROXIMAL END OF THE STENT. IT WAS REPORTED THAT ALL OF THE STENTS HAD BEEN DEPLOYED EXCEPT FOR THE PROXIMAL END LOCATED BETWEEN THE TWO MARKER BANDS. DEPLOYMENT OF EACH STENT WAS COMPLETED, WITHIN APPROXIMATELY 1-2 SECONDS. NO ADDITIONAL MANEUVERS WERE REQUIRED DURING DEPLOYMENT OTHER THAN A BRIEF WAIT BEFORE THE DELIVERY SYSTEM WAS MOVED. FOLLOWING RELEASE, THE PROCEDURE WAS REPORTED TO HAVE PROCEEDED NORMALLY, AND THE DELIVERY SYSTEM W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962173 ↗
• MalfunctionJul 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 16X90X75CM VENOUS WALLSTENT WAS USED FOR TREATMENT. DURING THE PREPARATION, IT WAS FOUND THAT THE STENT WAS DAMAGE AND BENT. THE STENT REMAINS ENCLOSED IN ITS STERILE PACKAGING AND THE BOX WAS FINE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559729 ↗
• MalfunctionJul 23, 2024Difficult to Advance; Material Deformation; Packaging Problem; Difficult to Advance; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC VEIN. A 16X90X75CM VENOUS WALLSTENT SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT. UPON UNPACKING, THE PACKAGING WAS NOTED TO BE DAMAGED AND THE TIP END OF THE BODY OF THE STENT WAS NOTED TO BE BENT. THE WIRE WAS UNABLE TO ADVANCE THROUGH THE DEVICE. THE DEVICE WAS NEVER INTRODUCED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804753 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN. THE PATIENT PRESENTED WITH ILIAC COMPRESSION. A 16X90X75CM VENOUS WALLSTENT WAS INSERTED INTO THE PATIENT FOR TREATMENT. HOWEVER, THE PATIENT BEGAN COMPLAINING OF 10/10 PAIN AND UNABLE TO TOLERATE. ONCE THE DEVICE WAS REMOVED, THE PAIN SUBSIDED. THE PROCEDURE WAS ABORTED AND PHYSICIAN PLANS ON RESCHEDULING PROCEDURE FOR HOSPITAL WITH ANESTHESIA. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 15886971 ↗
• MalfunctionOct 4, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16X90X75CM VENOUS WALLSTENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE FAILED TO DEPLOY. THE STENT WAS REMOVED SAFELY FROM THE PATIENT. THE PROCEDURE WAS CANCELLED AND WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538850 ↗
• InjuryOct 1, 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 15524657 ↗
• MalfunctionMay 28, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE WALLSTENT DEPLOYED WITHIN THE SHEATH AND THE STENT HAD TO BE REMOVED VIA A SMALL CUT INCISION. A 16X90X75 VENOUS WALLSTENT WAS SELECTED FOR USE FOR A VENOGRAM PROCEDURE IN THE DISTAL COMMON ILIAC VEIN. THE LESION WAS NEAR OCCLUDED AND THE TORTUOSITY WAS VERY COMPLEX. THE LESION WAS PREDILATED TO 12MM. DURING THE PROCEDURE, THE ENTIRE STENT WAS REPORTED TO HAVE DEPLOYED IN THE 8FR SHEATH. THE STENT WAS REMOVED FROM THE PATIENT VIA A SMALL CUTDOWN INCISION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11902270 ↗