Venovo® VENUM14140Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741103469), received between Nov 25, 2020 and May 15, 2026 — classified as 31 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Migration or Expulsion of Device

  ON A(B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING VENOVO. IT WAS REPORTED THAT AFTER DEPLOYMENT THE STENT STARTED TO MIGRATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182561 ↗
• MalfunctionNov 25, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING VENOVO VENOUS STENT DEVICE. DURING PROCEDURE, THE DEVICE ALLEGEDLY HAD MALFUNCTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641940 ↗
• MalfunctionFeb 18, 2025Premature Activation; Difficult to Remove; Premature Activation; Difficult to Remove

  IT WAS REPORTED THAT POST A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE GUIDEWIRE ALLEGEDLY UNABLE TO BE REMOVED. IT WAS FURTHER REPORTED THAT THE HANDLE AND THE CATHETER LINE WAS TAKEN OFF THE ROLLER BALL IN ORDER TO GET THE DEVICE OFF THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398407 ↗
• MalfunctionApr 13, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE IN LEFT COMMON ILIAC VEIN VIA RIGHT INTERNAL JUGULAR ACCESS, THE INNER CATHETER DIDN'T WALK OFF THE WIRE, AND APPEARED TO BE STUCK AT THE PROXIMAL END OF THE STENT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAITED A BIT LONGER AND THEN MADE SURE THE WHEEL WAS FULLY WHEELED BACK BUT STILL HAD RESISTANCE. FURTHERMORE, UNDER FLUOROSCOPY THE PHYSICIAN YANKED THE CATHETER AND COULD SEE THAT PART OF THE STENT THAT WAS STUCK TO THE CATHETER LOOKED A LITTLE FUNKY. REPORTEDLY, A BALLOON WAS USED TO SMOOTHEN THE STENT OUT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740518 ↗
• MalfunctionFeb 17, 2023Material Fragmentation; Material Deformation; Activation Failure; Material Fragmentation; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE FRONTAL FEMORAL THROUGH ILIAC ACCESS, THE STENT ALLEGEDLY STICKING AND CATCHING AT DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY KINKED DURING THE REMOVAL FROM THE PATIENT CAUSING THE DIFFICULTY IN REMOVING THE DELIVERY SYSTEM THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395011 ↗
• MalfunctionFeb 17, 2023Material Fragmentation; Material Deformation; Activation Failure; Material Fragmentation; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE FRONTAL FEMORAL THROUGH ILIAC ACCESS, THE STENT ALLEGEDLY STICKING AND CATCHING AT DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY KINKED DURING THE REMOVAL FROM THE PATIENT CAUSING THE DIFFICULTY IN REMOVING THE DELIVERY SYSTEM THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395009 ↗
• MalfunctionFeb 17, 2023Material Fragmentation; Material Deformation; Activation Failure; Material Fragmentation; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY STICKING AND CATCHING AT DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16394967 ↗
• MalfunctionFeb 9, 2023Material Fragmentation; Material Deformation; Activation Failure; Material Fragmentation; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE FRONTAL FEMORAL THROUGH ILIAC ACCESS, THE STENT ALLEGEDLY STICKING AND CATCHING AT DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY KINKED DURING THE REMOVAL FROM THE PATIENT CAUSING THE DIFFICULTY IN REMOVING THE DELIVERY SYSTEM THROUGH THE INTRODUCER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16331500 ↗
• MalfunctionMay 27, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE IN THE ILIAC VEINS WITH FEMORAL ACCESS, THE STENT WAS ALLEGEDLY FAILED TO EXPAND AS THE PROXIMAL END OF THE STENT WAS STUCK TO THE INNER CATHETER. REPORTEDLY, THE USER DID NOT WANT TO WAIT LONGER THAN FOUR MINUTES, SO THE SYSTEM WAS TORN APART AND THE STENT WAS EXPANDED BY PUSHING THE SHEATH FORWARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893168 ↗
• MalfunctionMay 12, 2021Fracture; Misfire; Malposition of Device; Fracture; Misfire; Malposition of Device

  IT WAS REPORTED THAT DURING STENT PLACEMENT IN THE ILIAC VEIN, THROUGH LEFT FEMORAL VEIN, THE STENT ALLEGEDLY JUMPED FORWARD, FRACTURED, AND PARTIALLY DEPLOYED. THEREFORE, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT AND A SECOND STENT WAS DEPLOYED INSIDE THE FRACTURED STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811347 ↗
• MalfunctionApr 22, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND AT THE END. TWISTING THE HANDLE FINALLY RELEASED THE STENT FROM THE INNER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11705143 ↗
• MalfunctionMar 31, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT IN THE ILIAC VEIN THE STENT PROXIMAL END ALLEGEDLY FAILED TO EXPAND. ROTATION OF THE SYSTEM AND WAITING FOR 30 SECONDS LED TO FINAL STENT EXPANSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594536 ↗
• MalfunctionMar 25, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PROXIMAL END OF THE STENT DID NOT FULLY EXPAND. IT WAS FURTHER REPORTED THAT THE CATHETER TO BE STUCK ON THE STENT WHEN TRYING TO REMOVE THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566868 ↗
• MalfunctionMar 24, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH RIGHT 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 11559074 ↗
• MalfunctionMar 24, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH RIGHT 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 11559073 ↗
• MalfunctionMar 15, 2021Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE THROUGH BILATERAL POP, THE STENT ALLEGEDLY HAD EXPANSION ISSUE. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY WAS DIFFICULT TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479808 ↗
• MalfunctionMar 1, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395157 ↗
• MalfunctionFeb 23, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PROXIMAL PORTION OF THE STENT NOT FULLY EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364187 ↗
• MalfunctionFeb 23, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT COMMON ILIAC VEIN, THE PROXIMAL END OF THE STENT WAS ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE STENT EVENTUALLY EXPANDED BY ROTATING THE DEPLOYMENT HANDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364134 ↗
• MalfunctionJan 22, 2021Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT DURING A TREATMENT IN THE INTERNAL JUGULAR, THE DEVICE ALLEGEDLY DIFFICULT TO REMOVE. IT WAS FURTHER REPORTED THAT, THE STENT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11213158 ↗
• MalfunctionJan 13, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND AT THE DISTAL END. IT WAS FURTHER REPORTED THAT THE DEPLOYMENT SYSTEM WAS TWISTED TO DEPLOY COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162210 ↗
• MalfunctionJan 6, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH LEFT POPLITEAL, THE DEVICE ALLEGEDLY FAILED TO EXPAND IN THE DISTAL END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128953 ↗
• MalfunctionJan 6, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE ILIOFEMORAL VEINS THROUGH POPLITEAL ACCESS, THE DEVICE ALLEGEDLY FAILED TO EXPAND FROM THE CATHETER INITIALLY AT ONE SPOT. THE STENT FINALLY OPENED UPON TWISTING THE SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11128896 ↗
• MalfunctionJan 4, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH BILATERAL GREATER SAPHENOUS VEIN AND RIGHT INTERNAL JUGULAR, THE DEVICE ALLEGEDLY FAILED TO EXPAND IN THE PROXIMAL END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106566 ↗
• MalfunctionDec 30, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE STENT ALLEGEDLY FAILED TO EXPAND AT THE DISTAL END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094161 ↗