VENOUS WALLSTENT™ H74912044189070Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729979616), received between Nov 11, 2020 and Mar 12, 2026 — classified as 3 injuries, 6 malfunctions.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 18X90X75CM VENOUS WALLSTENT SELF EXPANDING WAS SELECTED FOR USE. DURING DEVICE PREPARATION, THE DEVICE WAS REMOVED FROM THE BOX AND THE PACKAGE WAS OPENED, AT WHICH TIME THE STENT HOUSING WAS OBSERVED TO BE DAMAGED, RESULTING IN DAMAGE TO THE STENT CATHETER. 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 24584103 ↗
• InjuryApr 1, 2024Positioning Problem; Activation Failure; Positioning Problem; Activation Failure

  IT WAS REPORTED THAT DIFFICULTY POSITIONING OCCURRED. PATIENT UNDERWENT A VENOGRAM PROCEDURE WHERE THE PHYSICIAN OBTAINED VENOUS ACCESS AND DID AN INITIAL INTERVASCULAR ULTRASOUND RUN. THE TARGET WAS A COMPRESSION LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED COMMON FEMORAL VEIN. AN 18X90X75CM VENOUS WALLSTENT WAS IMPLANTED, BUT IT WAS NOTED THAT THE DISTAL TIP WAS NOT EXPANDING. AN 18-6/5.8/75 XXL ESOPHAGEAL BALLOON DILATOR WAS ADVANCED FOR DILATION, BUT IT WOULD NOT TRACK THROUGH THE DISTAL PORTION OF THE STENT. A SMALLER 035 NON-BOSTON SCIENTIFIC BALLOON WAS SWITCHED WHICH SUCCESSFULLY TRACKED AND EXPANDED. THE FLOW POST-STENT WAS UNSATISFACTORY AFTER SHOOTING CONTRAST ON FLUOROSCOPY. THE PHYSICIAN MADE FURTHER ACCESS BY FIRST INSERTING THE NON-BSC BALLOON FOLLOWED BY THE XXL BALLOON. AFTER THE FIRST INFLATION, THE XXL BALLOON RUPTURED. INFLATION WAS QUICK, UP AND DOWN, AND WAS ESTIMATED TO BE UNDER 30 SECONDS. THE DEVICE WAS REMOVED AND REPLACED BY A DIFFERENT MODEL TO COMPLETE THE PROCEDURE. THE WALLSTENT FULLY EXPANDED IN WHICH THE CASE ENDED WITH A GOOD FLOW. THE STENT STRUTS WERE ASSUMED TO BE STUCK TOGETHER, BUT AFTER REVIEWING POST-CASE, THEY MAY HAVE INITIALLY STUCK AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014533 ↗
• MalfunctionMay 15, 2023Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 60% COMPRESSION STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT COMMON TO EXTERNAL ILIAC VEIN. A 18X90X75CM VENOUS WALLSTENT WAS INSERTED THROUGH LEFT COMMON FEMORAL VEIN OVER A 0.35 AMPLATZ WIRE. HOWEVER, SLIGHTLY DIFFICULTY IN ADVANCING THE TORTUOUS VESSEL WAS ENCOUNTERED. IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED AND WAS TOO SHORT. RECAPTURING THE STENT WAS DIFFICULT AND HAD TO DEPLOY IT AND CAPTURE IT IN TORTUROUS AREA TO FULLY RECAPTURE. DIFFICULTY REMOVAL OF THE STENT WAS ALSO ENCOUNTERED. SUBSEQUENTLY, IT WAS PULLED OUT SUCCESSFULLY INTACT FROM THE PATIENT. UPON REMOVAL OF THE STENT, POSSIBLE KINK WAS NOTED WITH THE SHAFT. ANOTHER 18X90X75 VENOUS WALLSTENT WAS USED AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930195 ↗
• MalfunctionApr 22, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS DAMAGED. AN 18MM X 90MM X 75CM VENOUS WALLSTENT WAS SELECTED FOR USE IN THE LEFT COMMON ILIAC VEIN. THE 90% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS ANATOMY. DURING THE PROCEDURE, THE WALLSTENT BECAME STUCK AT THE BIFURCATION, AND IT WAS DIFFICULT TO CROSS THE ANATOMY. THE DEVICE WAS REMOVED OVER THE 0.035 WIRE. UPON REMOVAL, IT WAS NOTED THAT THE TIP OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190371 ↗
• InjuryFeb 15, 2022Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT THE STENT FORESHORTENED AND WAS UNABLE TO BE RECONSTRAINED. A 18MM X 90MM X 75CM VENOUS WALLSTENT WAS SELECTED FOR USE IN THE LEFT COMMON ILIAC VEIN FOR TREATMENT OF MAY-THURNER SYNDROME. THE TARGET LESION WAS 70% STENOSED WITH NO VESSEL TORTUOSITY. DURING THE PROCEDURE WHILE TRYING TO DEPLOY THE VENOUS WALLSTENT, THE STENT KEPT FORESHORTENING. AN ATTEMPT WAS MADE TO RECAPTURE THE STENT AND MOVE IT MORE PROXIMAL, BUT THE STENT WOULD NOT RE-SHEATH. THE SYSTEM WOULD NOT MOVE BACK OVER THE STENT, AND IT WAS NOTED BY THE PHYSICIAN TO BE WELL ABOVE THE POINT OF NO RETURN. THE STENT WAS ULTIMATELY DEPLOYED. A 18MM X 60MM X 75CM VENOUS WALLSTENT WAS PLACED ON THE PROXIMAL END OF THE FIRST STENT WHERE IT HAD FORESHORTENED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535264 ↗
• MalfunctionNov 16, 2021Difficult or Delayed Positioning; Mechanical Problem; Deformation Due to Compressive Stress; Difficult or Delayed Positioning; Mechanical Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE RECONSTRAINED. VASCULAR ACCESS WAS OBTAINED VIA THE JUGULAR WITH A 11FR SHEATH. A 18X90X75CM VENOUS WALLSTENT WAS SELECTED FOR A PROCEDURE IN THE NON-THROMBOTIC LEFT ILIAC VEIN. THE LESION HAD CHRONIC DISEASED TISSUE, WAS MILDLY TORTUOUS, AND WAS APPROXIMATELY 56 PERCENT STENOSED. A 035 NON-BOSTON SCIENTIFIC GUIDEWIRE EASILY CROSSED THE IVUS SUBSTANTIATED LESION. THE WALLSTENT WAS LOADED OVER THE SAME 035 GUIDEWIRE AND EASILY ADVANCED THROUGH THE LESION. FIFTY PERCENT OF THE STENT DEPLOYED. AN ATTEMPT WAS MADE TO RECONSTRAIN THE STENT FOR THE PURPOSE OF REPOSITIONING; HOWEVER, THE STENT WAS UNABLE TO BE RECONSTRAINED AND 2CM OF THE STENT WAS EXPOSED. THE SIDEPORT WAS RE-FLUSHED WITH NO IMPROVEMENT. ONE CENTIMETER OF THE STENT WAS RECAPTURED USING PIN-PUSH MANEUVERS WITH GREATER FORCE. THE DELIVERY SHAFTS OF THE SHAFT DEPLOYMENT SYSTEM BECAME STUCK AND WOULD NOT ALLOW FOR EITHER PIN-PULL DEPLOYMENT OR PIN-PULL RECAPTURE. THE STENT WAS PULLED BACK INTO THE INFERIOR VENA CAVA (IVC) BUT WAS STILL UNABLE TO RECONSTRAIN THE LAST 1 CM. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. THE DELIVERY SHAFT WAS COMPRESSED LONGITUDINALLY IN AN ACCO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822905 ↗
• MalfunctionJul 13, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE WIRE. A 18X90X75CM VENOUS WALLSTENT WAS SELECTED FOR A PATIENT LEFT LEG VENOGRAM PROCEDURE TO TREAT POOR VENOUS RETURN. THE LESION WAS MILDLY CALCIFIED AND MILDLY TORTUOUS. THE DEVICE WAS IMPLANTED, AND THEN UPON WITHDRAWAL/CLOSURE THE DEVICE BECAME STUCK ON THE WIRE. THE WIRE AND THE STENT DELIVERY SYSTEM WERE REMOVED AS A UNIT. THE DEVICES WERE REMOVED FROM THE PATIENT INTACT. ONCE OUTSIDE THE PATIENT, THE PHYSICIAN WIGGLED, MOVED, AND ADJUSTED THE CATHETER UNTIL IT FINALLY CAME UNSTUCK AND WAS ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160338 ↗
• MalfunctionMay 26, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE STENT INSIDE THE PACKAGING WAS THE INCORRECT SIZE. A VENOUS WALLSTENT WAS SELECTED FOR USE IN A VENOUS STENTING PROCEDURE TO TREAT AN 85MM LONG LESION IN THE LEFT ILIAC VEIN. DURING THE PROCEDURE, WHEN THE DEVICE WAS PLACED UNDER FLUOROSCOPY, IT WAS NOTED THAT THE STENT WAS NOT THE SIZE LABELED ON THE BOX. IT WAS LABELED 18MM X 90MM X 75CM ON BOTH THE INNER POUCH AND THE OUTER CARTON. RADIOGRAPHICALLY, THE DEVICE APPEARED TO BE AN 18MM X 60MM STENT MOUNTED ON AN 18MM X 90MM DELIVERY CATHETER. THE STENT WAS NOT DEPLOYED, AND IT WAS REMOVED FROM THE BODY. ANOTHER 18MM X 90MM X 75CM VENOUS WALLSTENT WAS DEPLOYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887029 ↗
• InjuryNov 11, 2020Migration; Migration

  IT WAS REPORTED THAT THE STENT MIGRATED. AN 18X90X75CM VENOUS WALLSTENT WAS SELECTED AND 16X60X75CM WALLSTENT ENDOPROSTHESIS WERE SELECTED FOR USE WITHIN THE RIGHT COMMON ILIAC VEIN AND EXTERNAL ILIAC VEIN. THE LESION WAS 50% STENOSED, NON-CALCIFIED, AND NON-TORTUOUS. THE VENOUS WALLSTENT WAS PLACED IN THE RIGHT 15.5MM DIAMETER COMMON ILIAC VEIN AND THE WALLSTENT ENDOPROSTHESIS WAS OVERLAPPED APPROXIMATELY 2CM INTO THE 14MM DIAMETER VESSEL EXTENDING INTO THE RIGHT EXTERNAL ILIAC VEIN. POST DILATION WAS PERFORMED. THE STENTS WERE FULLY APPOSED. AFTER, THE VENOUS WALLSTENT MIGRATED INTO THE INFERIOR VENA CAVA (IVC) AND THE WALLSTENT ENDOPROSTHESIS MIGRATED SLIGHTLY AS WELL. DUE TO THE MIGRATION, ANOTHER 18X90 WALLSTENT WAS PLACED BETWEEN THE INITIAL TWO IMPLANTED STENTS. NO ADDITIONAL MIGRATION WAS OBSERVED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10826095 ↗