VENOUS WALLSTENT™ H74912044164070Recalls & reported problems
Boston Scientific Corporation · Self-Expanding Stent · Class 3 · Implant
All models of VENOUS WALLSTENT (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729979562), received between May 26, 2022 and May 26, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Device” (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
Device problems
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE STENT FORESHORTENED. A 16MM X 40MM X 75CM VENOUS WALLSTENT WAS SELECTED FOR USE IN AN ILIAC VEIN STENTING PROCEDURE. AFTER MEASURING THE LEFT COMMON ILIAC FOR SIZE BY INTRAVASCULAR ULTRASOUND (IVUS), IT WAS DETERMINED THAT THE VESSEL WAS 12MM. AFTER THE STENT WAS DEPLOYED AND POST DILATED WITH A 16MM BALLOON, IVUS WAS USED TO VISUALIZE THE STENT; THE STENT HAD GOOD WALL APPOSITION. THERE WAS ALSO GOOD FLOW BY VENOGRAM, BUT IT WAS OBSERVED THAT THE STENT FORESHORTENED APPROXIMATELY 10MM FROM THE DISTAL END. UPON ADVANCING THE IVUS CATHETER TO MEASURE THE LENGTH NEEDED FOR A SECOND STENT, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE STENT TURNED ON ITS SIDE WITHIN THE VESSEL. AT THIS POINT, THE PHYSICIAN FELT THAT THE STENT WAS UNDERSIZED AND AN 18MM STENT WAS NEEDED IN ORDER TO ENTRAP THE FIRST STENT. AN 18MM X 60MM X 75CM VENOUS WALLSTENT WAS ADVANCED AND DEPLOYED ENTRAPPING THE 16MM X 40MM STENT. THERE WAS GOOD FLOW SEEN BY VENOGRAM POST STENTING, AND GOOD WALL APPOSITION WAS NOTED BY IVUS. THE PATIENT DID WELL AND THERE WERE NO OTHER COMPLICATIONS. THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14516711 ↗
Other Stent, iliac vein devices
- Abre™ AB9U14080090Medtronic, Inc. · Stent, iliac vein2 recalls9 reports
- Venovo® VENUM16100Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall55 reports
- Venovo® VENUM14080Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall36 reports
- Venovo® VENUM14120Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall33 reports
- Venovo® VENUM14140Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall31 reports
- Venovo® VENUM14100Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall30 reports
- Venovo® VENUM16120Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall29 reports
- Venovo® VENUM14160Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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