Venovo® VENUM16100Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741103582), received between Feb 5, 2021 and Aug 26, 2024 — classified as 55 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (54 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, NEAR THE DISTAL END OF BOTH STENT DEPLOYMENT, THE STENT ALLEGEDLY GOT STUCK DURING THE RELEASE AND DID NOT FULLY DEPLOYED. IT WAS FURTHER REPORTED THAT AFTER THE CATHETER WAS TWISTED, THE STENT GOT UNSTUCK AND FULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072676 ↗
• MalfunctionAug 26, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, NEAR THE DISTAL END OF BOTH STENT DEPLOYMENT, THE STENT ALLEGEDLY GOT STUCK DURING THE RELEASE AND DID NOT FULLY DEPLOYED. IT WAS FURTHER REPORTED THAT AFTER THE CATHETER WAS TWISTED, THE STENT GOT UNSTUCK AND FULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072674 ↗
• MalfunctionMar 5, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE PROXIMAL PORTION OF THE STENT ALLEGEDLY DID NOT FULLY RELEASE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN ROTATED THE HANDLE IN AN ATTEMPT TO FREE THE STENT FROM THE DELIVERY CATHETER. FURTHERMORE, A PORTION OF THE STENT BECAME UNSTUCK WITH THIS METHOD BUT ONE SMALL PART STILL REMAINED ATTACHED AND IT WAS FINALLY RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835527 ↗
• MalfunctionFeb 23, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE PROXIMAL END OF THE STENT ALLEGEDLY DID NOT FULLY DETACH FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT EVEN AFTER ONE MINUTE, THE STENT ALLEGEDLY DID NOT RELEASE. REPORTEDLY, THE PHYSICIAN ROTATED THE DEPLOYMENT HANDLE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765798 ↗
• MalfunctionOct 26, 2023Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIOFEMORAL VESSEL VIA THE LEFT LEG POPLITEAL ACCESS, THE STENT ALLEGEDLY DID NOT OPENED COMPLETELY AND GOT STUCK. IT WAS FURTHER REPORTED THAT THE PHYSICIAN TRIED TO PULL TO FIX THE STENT AND AFTER COMPLETE EXPANSION, THE LAST PART OF THE STENT WAS ALLEGEDLY TWISTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18009439 ↗
• MalfunctionSep 6, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY STICKING DURING DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE CATHETER WAS PUSHED PROXIMALLY AND SLIGHTLY TWISTED IN AND THEN THE STENT WAS RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17688440 ↗
• MalfunctionSep 5, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC VEIN VIA SUPERFICIAL FEMORAL ARTERY ACCESS, THE PROXIMAL SECTION OF THE STENT ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681485 ↗
• MalfunctionJul 13, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC VEIN, THE STENT ALLEGEDLY GOT STUCK ON THE CATHETER AND DID NOT FULLY DEPLOY FOR TWO TO THREE MINUTES. IT WAS FURTHER REPORTED THAT THE CATHETER HANDLE WAS ROTATED OVER THE WIRE IN ORDER TO RELEASE THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315736 ↗
• MalfunctionJun 30, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE IN COMMON ILIAC VEIN VIA LEFT POPLITEAL ACCESS, THE STENT ALLEGEDLY GOT STUCK ON THE INNER CATHETER STENT CUSHION FOR ABOUT TWO MINUTES BEFORE RELEASED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17235812 ↗
• MalfunctionJun 6, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY STUCK TO THE CATHETER FOR TWO TO THREE MINUTES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069340 ↗
• MalfunctionJun 1, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY STUCK AND IT WAS CUSHIONED THAT WOULD NOT RELEASE AND EVENTUALLY DISLODGED FROM THE CATHETER AND SLID DOWN TO THE TIP. IT WAS FURTHER REPORTED THAT THE SHEATH WAS USED FOR DEPLOYING THE STENT OFF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038682 ↗
• MalfunctionMay 31, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE STENT CUSHION PORTION WAS ALLEGEDLY STUCK FOR FOUR MINUTES. THE PROCEDURE WAS COMPLETED BY USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029019 ↗
• MalfunctionMay 28, 2023Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT COMMON ILIAC VEIN VIA LEFT UPPER SAPHENOUS VEIN, THE STENT WAS ALLEGEDLY UNABLE TO BE DEPLOYED DURING THE FINAL STEPS OF DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016092 ↗
• MalfunctionMay 24, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, WHEN TRYING TO REMOVE THE DELIVERY SYSTEM IT WAS ALLEGEDLY PULLING ON THE STENT. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY DISCONNECTED BY PUSHING THE DELIVERY SYSTEM FORWARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993902 ↗
• MalfunctionMay 22, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN AND INTO THE INFERIOR VENA CAVA VIA BILATERAL GROIN ACCESS, STENT WAS ALLEGEDLY STUCK TO THE STENT CUSHION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973904 ↗
• MalfunctionApr 28, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT ILIAC VIA INTERNAL JUGULAR ACCESS, ONLY PART OF THE STENT ALLEGEDLY EXPANDED SLOWLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831027 ↗
• MalfunctionApr 21, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC VEIN VIA BILATERAL COMMON FEMORAL, THE PROXIMAL PORTION OF THE STENT ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16789936 ↗
• MalfunctionApr 21, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC VEIN VIA BILATERAL COMMON FEMORAL, THE PROXIMAL PORTION OF THE STENT ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16789898 ↗
• MalfunctionApr 15, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA INTERNAL JUGULAR ACCESS, STENT ALLEGEDLY ADHERED TO THE DELIVERY SYSTEM FOR APPROXIMATELY TWENTY FIVE TO THIRTY SECONDS AND THEN RELEASED. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER ALLEGEDLY REQUIRED TO SLIGHTLY TWIST THE DELIVERY SYSTEM TO GET THE STENT TO FULLY RELEASE. REPORTEDLY THE STENT WAS SUCCESSFULLY DEPLOYED AND COVERED THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748434 ↗
• MalfunctionApr 15, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA INTERNAL JUGULAR ACCESS, STENT ALLEGEDLY ADHERED TO THE DELIVERY SYSTEM FOR APPROXIMATELY TWENTY FIVE TO THIRTY SECONDS, AND THEN RELEASED. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER ALLEGEDLY REQUIRED TO SLIGHTLY TWIST THE DELIVERY SYSTEM TO GET THE STENT TO FULLY EXPAND. REPORTEDLY THE STENT WAS SUCCESSFULLY DEPLOYED, AND COVERED THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748433 ↗
• MalfunctionApr 15, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA INTERNAL JUGULAR ACCESS TO TREAT A VENOUS GRAFT, STENT ALLEGEDLY ADHERED TO THE DELIVERY SYSTEM FOR APPROXIMATELY TWENTY FIVE TO THIRTY SECONDS, AND THEN RELEASED. REPORTEDLY THE STENT WAS SUCCESSFULLY DEPLOYED, AND COVERED THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748432 ↗
• MalfunctionApr 13, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A BILATERAL STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE LAST PART OF THE STENT ALLEGEDLY STUCK TO THE SYSTEM, AND WAS ADHERED TO THE CATHETER ON THE PROXIMAL END OF THE STENT. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY FAILED TO EXPAND FOR ABOUT SIXTY SECONDS. REPORTEDLY THE HEALTH CARE PROVIDER TWISTED THE CATHETER AND APPROXIMATELY AFTER ONE MINUTE THE STENT FULLY RELEASED AND EXPANDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732189 ↗
• MalfunctionApr 10, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC VEIN VIA COMMON FEMORAL VEIN, THE STENT ALLEGEDLY TOOK MORE THAN FOUR MINUTES TO RELEASE FROM DEPLOYMENT CATHETER AFTER BEING DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706166 ↗
• 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 16689911 ↗
• 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 16689907 ↗