VENOUS WALLSTENT™ H74912044166070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729979579), received between Nov 3, 2022 and Mar 5, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED REQUIRING PATIENT HOSPITALIZATION. THE TOTALLY OCCLUDED AND CONCENTRIC TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT COMMON ILIAC VEIN. A 16X60X75CM VENOUS WALLSTENT SELF-EXPANDING WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, AFTER GAINING ACCESS TO BOTH FEMORAL VEINS AND THE RIGHT FEMORAL ARTERY, THE PHYSICIAN PROCEEDED WITH VENOGRAPHY AND ARTERIOGRAPHY SIMULTANEOUSLY TO DETERMINE THE EXACT POINT OF COMPRESSION OF THE LEFT COMMON ILIAC VEIN (LCIV). A HYDROPHILIC 0.035" GUIDEWIRE WAS PASSED TO THE INFERIOR VENA CAVA (IVC), AND A 3.5 JF 6FR CATHETER WAS PLACED IN THE PROXIMAL LCIV. AN OPTICROSS 18 IVUS CATHETER TO PERFORM A PULLBACK IVUS RUN, WHICH SHOWED THE EXACT COMPRESSION SITE AND LENGTH OF THE PROXIMAL LCIV COMPRESSION. FOLLOWING THIS, THE 16X60 MM VENOUS WALLSTENT WAS PLACED IN THE OSTIAL-PROXIMAL LCIV, WITH THE PROXIMAL EDGE OVERHANGING 1 CM INSIDE THE IVC FOR BETTER ANCHORING AND REDUCED RISK OF MIGRATION. UNDER FLUOROSCOPY, FULL DELIVERY AND DEPLOYMENT OF THE STENT IN THE LCIV WAS NOTED. HOWEVER, WHEN REMOVING THE DELIVERY CATHETER, THE VENOUS WALLSTENT HAD COME OUT ENTIRELY WITH THE DELIVERY C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524714 ↗
• MalfunctionMay 22, 2025Positioning Failure; Device-Device Incompatibility; Material Deformation; Positioning Failure; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 16X60X75CM VENOUS WALLSTENT SELF-EXPANDING WAS SELECTED FOR USE TO TREAT MAY-THURNER SYNDROME. DURING STENT IMPLANTATION, IT WAS NOTED THAT THE DISTAL TIP APPEARED CRUSHED. ADDITIONALLY, THE GUIDEWIRE WAS NOT PROPERLY POSITIONED, AND IT HAD SLIGHTLY MIGRATED. THE STENT WAS NOT DEPLOYED AND WAS REMOVED, AND PROCEDURE WAS COMPLETED WITH ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073917 ↗
• InjuryApr 2, 2024Migration; Migration

  IT WAS REPORTED VIA LITERATURE ARTICLE THAT STENT MIGRATION OCCURRED. A 16X60MM VENOUS WALLSTENT WAS IMPLANTED IN THE LEFT ILIAC VEIN 10 MONTHS PRIOR TO PRESENTATION. TWO DAYS AFTER THE PROCEDURE, THE PATIENT WENT TO A HOSPITAL COMPLAINING OF CHEST PAIN. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED AT THE OTHER INSTITUTION AND SHOWED AN "UNCLEAR ECHO DENSITY IN THE RIGHT ATRIUM, WHICH WAS SUSPECTED TO BE AN ARTIFACT." A CORONARY ANGIOGRAM SHOWED NONOBSTRUCTIVE CORONARY ARTERY DISEASE. BASED ON THE PREVIOUS REPORT, A TRANSTHORACIC ECHOCARDIOGRAPHY WAS ORDERED THAT SHOWED A FOREIGN BODY IN THE RIGHT ATRIAL CAVITY EXTENDING ACROSS THE TRICUSPID VALVE (TV). A TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED, WHICH SHOWED A DISLODGED VASCULAR STENT IN THE RIGHT ATRIUM MEASURING 5.5 X 1.6 CM. THE STENT WAS IMPINGING ON THE TV, CAUSING SEVERE TRICUSPID REGURGITATION. THE PATIENT WAS ADMITTED TO CARDIOLOGY SERVICE AND PLACED ON HEPARIN FOR ANTICOAGULATION. COMPUTED TOMOGRAPHY OF THE CHEST REPORTED A TUBULAR RADIOPAQUE DENSITY, IN THE RIGHT ATRIUM, PARTIALLY EXTENDING INTO THE RIGHT VENTRICLE. FOLLOWING A MULTIDISCIPLINARY MEETING INVOLVING INTERVENTIONAL CARDIOLOGY, VASCULAR SURGERY, AND C

  Patient problems: Chest Pain; Valvular Insufficiency/ Regurgitation

  MAUDE report 19028642 ↗
• InjuryNov 3, 2022Migration; Migration

  IT WAS REPORTED THAT THE STENTS MIGRATED AND REQUIRED EXPLANT. ON (B)(6) 2020, A 16X60 VENOUS WALLSTENT WAS IMPLANTED IN THE EXTERNAL ILIAC VEIN. THE PATIENT PRESENTED WITH RIGHT COMMON ILIAC AND EXTERNAL ILIAC VEIN COMPRESSION. IVUS IMAGING WAS OBTAINED ALONG WITH MEASUREMENTS, AND A PRE-DILATION OF THE COMMON ILIAC AND EXTERNAL ILIAC WAS PERFORMED WITH A 14X60 AND A 16X60 XXL BALLOON. AN ADDITIONAL IVUS RUN WAS RECORDED, AND IT WAS NOTED THAT THERE WAS RECOIL. THE DECISION WAS MADE TO PLACE A 14X60 VICI STENT IN THE RIGHT COMMON ILIAC VEIN. THERE WAS STILL COMPRESSION IN THE EXTERNAL ILIAC VEIN, SO AN ADDITIONAL STENT (16X60 VENOUS WALLSTENT) WAS PLACED IN THE EXTERNAL ILIAC VEIN. POST DILATION OF THE STENTS WAS PERFORMED. A FOLLOW UP INTRAVASCULAR ULTRASOUND EXAM REVEALED SIGNIFICANT IMPROVEMENT WITH AN INCREASE IN CROSS-SECTIONAL AREA. A VENOGRAM WAS ALSO PERFORMED, AND THE PHYSICIAN COMPLETED THE PROCEDURE. PATIENT TOLERATED THE PROCEDURE WELL AND RECOVERED WITH NO COMPLICATIONS. 6-MONTH FOLLOW UPS WERE PERFORMED WITH ULTRASOUND, AND THE STENTS WERE INTACT. SOMETIME IN THE TWO WEEKS PRIOR TO (B)(6) 2022, THE PATIENT PRESENTED WITH HEART PALPITATIONS. BOTH THE VICI AND VENOUS W

  Patient problems: Atrial Fibrillation; Unspecified Heart Problem

  MAUDE report 15720974 ↗