Venovo® VENUM20080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741103858), received between Feb 4, 2021 and Aug 26, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  ON (B)(6) 2025, A PATIENT PREPPED FOR A STENT PLACEMENT PROCEDURE USING VENOVO VENOUS STENT. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE ACTUAL PRODUCT DID NOT COME IN PROPER PACKAGING. IT WAS FURTHER REPORTED THAT THE PRODUCT WAS NOT PACKED IN A BOX BUT ONLY IN PLASTIC. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892843 ↗
• MalfunctionJun 16, 2023Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN SUPERIOR VENA CAVA VIA RIGHT BRACHIAL VEIN ACCESS, THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO EXPAND UPON DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17141895 ↗
• MalfunctionMay 8, 2023Difficult or Delayed Activation; Activation Failure; Difficult or Delayed Activation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN SUPERIOR VENA CAVA VIA RIGHT BRACHIAL VEIN ACCESS, THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO EXPAND UPON DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884147 ↗
• InjuryMay 20, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SOME TIME POST STENT PLACEMENT THE STENT ALLEGEDLY BENT. REPORTEDLY, AN ADDITIONAL PROCEDURE WAS REQUIRED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11853947 ↗
• MalfunctionMar 8, 2021Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH COMMON AND EXTERNAL ILIAC VEIN, THE STENT ALLEGEDLY GOT TWISTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11432212 ↗
• MalfunctionFeb 4, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE SYSTEM WOULD NOT RELEASE THE END OF THE STENT WHICH CAUSED A STRETCHING OF THE STENT AT THE PROXIMAL END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11277838 ↗
• MalfunctionFeb 4, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE END OF THE STENT WOULD NOT RELEASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11277339 ↗