Venovo® VENUM20140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741103889), received between Jan 22, 2025 and Mar 12, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY PLACED AFTER THE EXPIRED DATE. IT WAS FURTHER REPORTED THAT THE SALES REPRESENTATIVE PULLED THE DEVICE FROM HIS TRUNK STOCK, HANDED TO THE PHYSICIAN, AND EXPLAINED TO THE PHYSICIAN THAT THE PRODUCT IS EXPIRED. THE PHYSICIAN DECIDED TO USE THE EXPIRED DEVICE ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582128 ↗
• MalfunctionMar 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY PLACED AFTER THE EXPIRED DATE. IT WAS FURTHER REPORTED THAT THE SALES REPRESENTATIVE PULLED THE DEVICE FROM HIS TRUNK STOCK, HANDED TO THE PHYSICIAN, AND EXPLAINED TO THE PHYSICIAN THAT THE PRODUCT IS EXPIRED. THE PHYSICIAN DECIDED TO USE THE EXPIRED DEVICE ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582126 ↗
• MalfunctionMar 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY PLACED PAST EXPIRATION DATE. IT WAS FURTHER REPORTED THAT THE SALES REPRESENTATIVE WAS ON SITE WHEN PROCEDURE HAPPENED AND PROVIDED THE FACILITY WITH THE DEVICE, THEY WERE NOT AWARE TILL AFTER THE DEVICE WAS INSERTED INTO THE PATIENT AND THE STICKER WITH EXPIRATION DATE WAS PLACED INTO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581940 ↗
• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213738 ↗