Venovo® VENUM18160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741103759), received between Dec 15, 2020 and Mar 9, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Activation Failure

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING VENOVO VENOUS STENT. DURING THE PROCEDURE, THE DISTAL PORTION OF STENT DID NOT FULLY OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543648 ↗
• MalfunctionApr 10, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE BOTH EXTERNAL AND INTERNAL PACKAGING OF THE DEVICE ARRIVED WET AND DAMAGED. IT WAS FURTHER REPORTED THAT THE PACKAGING WAS ALLEGEDLY RIPPED OPEN, AND ALL OF THE CONTENT INSIDE OF THE CASE WERE SOAKED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16705827 ↗
• MalfunctionJan 11, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11152967 ↗
• MalfunctionDec 15, 2020Misfire; Material Deformation; Activation Failure; Misfire; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE ILIAC VEIN THROUGH FEMORAL ACCESS, THE STENT ALLEGEDLY WAS STUCK ON THE DELIVERY SYSTEM AND FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT AN ADDITIONAL STENT WAS PLACED BECAUSE THE STENT COLLAPSED AGAIN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11009853 ↗