Venovo® VENUL14040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741103483), received between Dec 21, 2020 and Jun 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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-1899-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE IN THE RIGHT BRACHIOCEPHALIC VEIN WITH FEMORAL ACCESS, THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO EXPAND BECAUSE IT WAS HUNG ON THE CUSHION AFTER COMPLETE RETRACTION OF THE STENT SHEATH. REPORTEDLY, THE USER LET SIT THE STENT FOR FIVE MINUTES; AFTER SPINNING HANDLE AND FORWARD PRESSURE THE STENT FINALLY EXPANDED AFTER SIX MINUTES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912731 ↗
• MalfunctionDec 21, 2020Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11044438 ↗