VENOUS WALLSTENTRecalls & reported problems across all models

We found 8 models of VENOUS WALLSTENT by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2020 and Mar 12, 2026 — classified as 15 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VENOUS WALLSTENT problems

VENOUS WALLSTENT models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VENOUS WALLSTENT™ H74912044169070

  Stent, iliac vein
  9 reports
• VENOUS WALLSTENT™ H74912044189070

  Stent, iliac vein
  9 reports
• VENOUS WALLSTENT™ H74912044208070

  Stent, iliac vein
  5 reports
• VENOUS WALLSTENT™ H74912044166070

  Stent, iliac vein
  4 reports
• VENOUS WALLSTENT™ H74912044186070

  Stent, iliac vein
  4 reports
• VENOUS WALLSTENT™ H74912044106870

  Stent, iliac vein
  1 report
• VENOUS WALLSTENT™ H74912044149070

  Stent, iliac vein
  1 report
• VENOUS WALLSTENT™ H74912044164070

  Stent, iliac vein
  1 report

Recent VENOUS WALLSTENT adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 12, 2025Premature Activation; Deformation Due to Compressive Stress; Premature Activation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DEVICE DEPLOYED PREMATURELY DURING REMOVAL FROM ITS PACKAGING. A 14 X 90 X 75 CM VENOUS WALLSTENT? STENT SELF EXPANDING WAS SELECTED FOR USE. DURING THE PREPARATION, THE PHYSICIAN OBSERVED THAT THE STENT WAS NOT PROPERLY MOUNTED ON THE SHAFT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534622 ↗
• MalfunctionNov 3, 2025Nonstandard Device; Incomplete or Missing Packaging; Defective Device; Wrong Label; Nonstandard Device; Incomplete or Missing Packaging; Defective Device; Wrong Label

  IT WAS REPORTED THAT LABELING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC VEIN. A 20X80X75CM VENOUS WALLSTENT STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT A POTENTIAL INCORRECT STENT WAS INSIDE THE PACKAGE. THE DEVICE WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE STENT FOUND TO BE THE WRONG SIZE DURING IVUS -POST DEPLOYMENT. THE STENT SUFFICIENTLY COVERS THE TARGET LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457559 ↗
• MalfunctionSep 16, 2025Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT HOLES IN THE CATHETER OCCURRED. THE 80% STENOSED TARGET LESION WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED. A 20X80X75CM VENOUS WALLSTENT WAS SELECTED FOR USE. DURING INSERTION, IT WAS NOTED THAT THERE WERE HOLES IN THE CATHETER AND THE MIDDLE OF THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A 20 X 80 WALLSTENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063356 ↗
• MalfunctionJul 25, 2025Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02JUL2025. IT WAS REPORTED THAT THE STENT UNABLE TO ADVANCE IN ANATOMY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VENOUS ARTERY. AFTER PREDILATION, THE STENOSIS WAS 40%. A 20X80X75CM VENOUS WALLSTENT SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO ADVANCE IN THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED DAMAGED DISTAL STENT WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22615429 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BALLOON WAS STUCK ON THE DISTAL END OF THE STENT, NECESSITATING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC VEIN, WHICH WAS MILDLY TORTUOUS, COMPRESSED, AND CALCIFIED. A 20X80X75CM VENOUS WALLSTENT WAS PLACED BY THE PHYSICIAN TO EXTEND A PREVIOUSLY PLACED STENT IN THE LEFT COMMON ILIAC VEIN. THE PHYSICIAN POST-DILATED THE LESION USING AN 18X4X75 XXL BALLOON CATHETER AND ATTEMPTED TO REPOSITION THE STENT DURING BALLOON INFLATION. HOWEVER, THE BALLOON BECAME STUCK AT THE DISTAL END OF THE WALLSTENT AND WOULD NOT RELEASE. WHEN APPLIED MORE FORCE, THE ENTIRE BALLOON DETACHED FROM THE CATHETER SHAFT. EFFORTS TO SNARE AND REMOVE THE BALLOON WERE UNSUCCESSFUL. THE BALLOON LODGED BETWEEN THE VESSEL WALL AND THE FIRST PLACED WALLSTENT IN THE LEFT COMMON ILIAC VEIN. AFTER UNSUCCESSFUL REMOVAL ATTEMPTS, THE PHYSICIAN DECIDED IT WOULD BE BEST TO LEAVE THE BALLOON CAPTURED BETWEEN THE STENT AND THE VESSEL WALL, AS IT WAS IMMOVABLE, AND THE PATIENT WAS ASYMPTOMATIC FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361307 ↗
• 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 ↗

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