Venovo® VENUM18080Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741103711), received between Jan 18, 2021 and May 15, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE FOR ILIAC VEIN COMPRESSION IN THE LEFT ILIAC VEIN VIA LEFT GROIN ACCESS, THE STENT REMAINED CRIMPED AT THE DISTAL PORTION AND ALLEGEDLY DID NOT PROPERLY DEPLOY EVEN AFTER THE STENT WAS FULLY RELEASED FROM THE CATHETER STENT PLATFORM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929796 ↗
• MalfunctionMar 24, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY HAD DIFFICULT TO EXPAND. IT WAS FURTHER REPORTED THAT PHYSICIAN TURN OFF THE SHAFT AND INSERTED TO DEPLOY THE STENT CORRECTLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559099 ↗
• MalfunctionMar 10, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH LEFT COMMON ILIAC, THE DEVICE ALLEGEDLY FAILED TO EXPAND IN THE PROXIMAL END. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE FOR POST DILATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11450012 ↗
• MalfunctionMar 10, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT DIDN¿T FULLY EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449748 ↗
• MalfunctionMar 8, 2021Positioning Failure; Fracture; Premature Activation; Malposition of Device; Activation Failure; Positioning Failure; Fracture; Premature Activation; Malposition of Device; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON AND EXTERNAL ILIAC VEIN, THE STENT ALLEGEDLY DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT THE STENT DEPLOYED AUTOMATICALLY AND GOT DEPLOYED IN THE WRONG VESSEL AND ENDED UP SMASHING IT AGAINST THE WALL AND ONTO ANOTHER STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11433324 ↗
• MalfunctionFeb 23, 2021Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE ILIAC VEIN WITH FEMORAL ACCESS, STENT ALLEGEDLY HAD EXPANSION ISSUE. IT WAS FURTHER REPORTED THAT THE DEPLOYMENT SYSTEM WAS DIFFICULT TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11363971 ↗
• MalfunctionFeb 17, 2021Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY TWISTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336469 ↗
• MalfunctionJan 18, 2021Fracture; Misfire; Detachment of Device or Device Component; Activation Failure; Fracture; Misfire; Detachment of Device or Device Component; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DISTAL PORTION OF STENT WAS ALLEGEDLY FRACTURED AND WOULD NOT ALLOW FOR A FULL DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE DISTAL PORTION REMAINED IN THE VESSEL AND THE PHYSICIAN REMOVED THE BROKEN STENT AND USED NEW STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11184703 ↗