Venovo® VENUM14120Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741103452), received between Nov 10, 2020 and Sep 22, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (27 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-1899-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Loss of or Failure to Bond; Positioning Failure

  On (b)(6) 2026, a patient underwent a stent placement procedure using a Venovo Venous Stent in the iliac vein via femoral access. During the procedure, it was reported that the stent failed to deploy as intended. The procedure was subsequently completed using another Venovo Venous Stent. The patient was reported to be in good condition, and there was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850444 ↗
• MalfunctionJun 19, 2026Loss of or Failure to Bond; Positioning Failure

  ON (B)(6), 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING VENOVO STENT FOR ILIAC VEIN THROMBOSIS. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562881 ↗
• MalfunctionMay 2, 2025Loss of or Failure to Bond; Positioning Failure; Loss of or Failure to Bond; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY NOT DEPLOYED UPON CORRECT PLACEMENT AND BOTH THUMBWHEELS SPINNING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950395 ↗
• MalfunctionMar 31, 2025Loss of or Failure to Bond; Misfire; Loss of or Failure to Bond; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT ILIAC VEIN VIA LEFT FEMORAL VEIN, THE STENT WAS ALLEGEDLY STOPPED DEPLOYED MIDWAY THROUGH. IT WAS FURTHER REPORTED THAT PHYSICIAN ALLEGEDLY HAD TO OPEN UP DEPLOYMENT HANDLE AND DEPLOY MANUALLY.. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729067 ↗
• MalfunctionJul 22, 2024Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT COMMON ILIAC VEIN VIA LEFT POPLITEAL VEIN, THERE WAS ALLEGEDLY HARD TIME ADVANCING THE STENT UP FROM THE POP VEIN INTO THE ILIAC VEIN. IT WAS FURTHER REPORTED THAT THE STENT OPENED WITHOUT ANY ISSUES, BUT THE ENDS NEAR THE INFERIOR VENA ALLEGEDLY REMAIN UNFLARED. REPORTEDLY, WHEN THE STENT WAS PULLED OUT OF THE CATHETER, THE STENT ENDS ALLEGEDLY FOLDED ON THE INSIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790767 ↗
• MalfunctionMay 31, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH RIGHT COMMON FEMORAL VEIN, THE DEVICE ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11906192 ↗
• MalfunctionMay 20, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT STENT WAS EXPANDED AFTER 30 SEC AND DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854179 ↗
• MalfunctionMay 20, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT PHYSICIAN ADVANCED THE SHEATH INTO PROXIMAL END OF STENT TO RELEASE THE SENT. REPORTEDLY STENT WAS DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854175 ↗
• MalfunctionMay 14, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FATHER REPORTED THAT STENT WAS EXPANDED AFTER THREE MINUTES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824807 ↗
• MalfunctionMay 11, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805132 ↗
• MalfunctionApr 21, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY BENT AT TIP AND CRUSHED OVER ITSELF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699240 ↗
• MalfunctionApr 19, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING VENOVO STENT DEPLOYMENT PROCEDURE THROUGH RIGHT FEMORAL VEIN VIA EXTERNAL ILIAC VEIN, THE STENT ALLEGEDLY HAD EXPANSION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11684300 ↗
• MalfunctionApr 19, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT ON BILATERAL ILIAC VIA BILATERAL POPLITEAL, THE STENT PROXIMAL END ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT STENT GOT DEPLOYED AFTER TWISTING THE DEPLOYMENT SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683806 ↗
• MalfunctionApr 5, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY HAD EXPANSION ISSUE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN ROTATED HANDLE AND THE STENT WAS RELEASED AFTER 30 SECONDS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612974 ↗
• MalfunctionMar 31, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT THE PROXIMAL END OF THE STENT ALLEGEDLY HAD EXPANSION ISSUE. THE STENT WAS RELEASED AFTER 30 SECONDS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593829 ↗
• MalfunctionMar 31, 2021Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT THE PROXIMAL END OF THE STENT ALLEGEDLY HAD EXPANSION ISSUE. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY DIFFICULT TO REMOVE. THE STENT WAS RELEASED AFTER 30 SECONDS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593781 ↗
• MalfunctionMar 29, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT THE STENT ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580848 ↗
• MalfunctionMar 29, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT POST STENT DEPLOYMENT THROUGH COMMON FEMORAL ARTERY THE STENT ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580846 ↗
• MalfunctionMar 24, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH LEFT EXTERNAL ILIAC VEIN, THE DEVICE ALLEGEDLY FAILED TO EXPAND IN THE PROXIMAL END. THE PROCEDURE WAS COMPLETED BY TWISTING AND TURNING THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559071 ↗
• MalfunctionMar 16, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING PORT PLACEMENT THE DEVICE ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494767 ↗
• MalfunctionMar 15, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE HANDLE WAS ROTATED AND THE STENT GOT RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479467 ↗
• MalfunctionMar 12, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY AT THE PROXIMAL END. IT WAS FURTHER REPORTED THAT THE HANDLE WAS ROTATED AND THE STENT GOT RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473137 ↗
• MalfunctionMar 4, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT, THE DEVICE ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408865 ↗
• MalfunctionFeb 24, 2021Difficult or Delayed Positioning; Positioning Failure; Activation Failure; Difficult or Delayed Positioning; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT AFTER ROTATION, THE STENT GOT RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371601 ↗
• MalfunctionFeb 10, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH THE ILIO FEMORAL AT THE BILATERAL POPLITEAL, THE DISTAL END OF THE STENT ALLEGEDLY FACED EXPANSION FAILURE. IT WAS FURTHER REPORTED THAT TWISTING THE DEPLOYMENT SYSTEM SUCCESSFULLY DEPLOYED THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306591 ↗