Venovo® VENUM16160Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741103612), received between Apr 5, 2021 and Sep 10, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 14, 2020Class IIOpen, Classified

   Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

   Z-1897-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Misfire; Misfire

  ON (B)(6), 2025, A 57-YEAR-OLD MALE PATIENT UNDERGONE A STENT PLACEMENT PROCEDURE FOR MAY THURNER SYNDROME IN THE LEFT ILIAC VEIN, WITH THE ACCESS SITE OF RIGHT INTERNAL JUGULAR VEIN, USING A VENOVO STENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER DEVICE, AND THERE WERE NO REPORTED INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013119 ↗
• MalfunctionApr 8, 2025Difficult or Delayed Activation; Material Deformation; Difficult or Delayed Activation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY DEPLOYED AFTER DELAYED. IT WAS FURTHER REPORTED DISTAL WAS SLIGHTLY FORESHORTEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21796884 ↗
• InjuryAug 25, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT APPROXIMATELY FORTY-SEVEN DAYS POST A STENT PLACEMENT, THE STENT HAD ALLEGEDLY MIGRATED FROM THE ILIAC VEIN INTO THE PATIENT'S INFERIOR VENA CAVA OR RIGHT ATRIUM UNDER COMPUTED TOMOGRAPHY EXAMINATION. IT WAS FURTHER REPORTED THAT AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE THE MIGRATED STENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20060572 ↗
• MalfunctionApr 10, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT COMMON ILIAC VEIN VIA THE DISTAL COMMON FEMORAL ACCESS, THE DISTAL END OF THE STENT ALLEGEDLY REMAINED ON THE RELEASE CATHETER. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY RELEASED OFF THE CATHETER AND DEPLOYED AS NORMAL AS THE PHYSICIAN WANTED WITHIN TEN SECONDS. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077812 ↗
• MalfunctionAug 2, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN VIA COMMON FEMORAL VEIN, THE DISTAL END OF STENT ALLEGEDLY STUCK ON DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE STENT EVENTUALLY DEPLOYED AFTER FIFTEEN SECONDS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17441572 ↗
• MalfunctionApr 6, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC FEMORAL ARTERY THROUGH POPLITEAL ACCESS, THE STENT WAS ALLEGEDLY STUCK ON CATHETER. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT DEPLOYED AND RELEASED PROPERLY FROM THE CATHETER. REPORTEDLY, PHYSICIAN HAD TO TWIST AND PULL THE CATHETER OFF OF STENT FOR THE STENT TO RELEASE. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687559 ↗
• MalfunctionMar 21, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT COMMON ILIAC VEIN VIA PROXIMAL FEMORAL VEIN, THE STENT ALLEGEDLY FAILED TO EXPAND. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584660 ↗
• MalfunctionMar 17, 2023Fracture; Activation Failure; Fracture; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE EXTERNAL ILIAC, THE STENT ALLEGEDLY EXCEEDED THE AMOUNT OF TIME EXPECTED BY THE PHYSICIAN TO RELEASE FROM THE DEPLOYMENT CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567727 ↗
• MalfunctionNov 15, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST STENT PLACEMENT, THE STENT ALLEGEDLY MIGRATED UP THE IVC TO THE RENAL VEINS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808951 ↗
• MalfunctionNov 15, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT APPROXIMATELY ONE YEAR POST STENT PLACEMENT, THE STENT ALLEGEDLY MIGRATED UP THE IVC TO THE RENAL VEINS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808950 ↗
• MalfunctionApr 20, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE THROUGH ILIAC VEIN VIA COMMON FEMORAL ARTERY, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD EXPANSION ISSUE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693628 ↗
• MalfunctionApr 15, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT POST STENT DEPLOYMENT PROCEDURE, THE CATHETER ALLEGEDLY GOT STUCK IN THE STENT AND FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT PHYSICIAN USED MORE PRESSURE TO REMOVE THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11669835 ↗
• MalfunctionApr 7, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT IN THE ILIAC VEINS THROUGH FEMORAL ACCESS, THE PROXIMAL END OF THE STENT DID NOT EXPAND. IT WAS FURTHER REPORTED THAT THE PHYSICIAN ROTATED THE HANDLE AND THE STENT FINALLY EXPANDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626949 ↗
• MalfunctionApr 5, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE IN THE RIGHT COMMON AND EXTERNAL ILIAC VEIN, THE DISTAL END OF THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT PHYSICIAN TWISTED THE DEPLOYMENT CATHETER AT HUB OF SHEATH, AND THE STENT GOT DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613265 ↗