Venovo® VENUL14160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741103544), received between Nov 20, 2020 and Apr 1, 2021 — classified as 4 malfunctions.

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

• MalfunctionApr 1, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DISTAL PORTION OF STENT DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT AFTER 3 MINUTES STENT FULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601084 ↗
• MalfunctionDec 29, 2020Difficult to Remove; Material Twisted/Bent; Activation Failure; Difficult to Remove; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT DURING A BILATERAL STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN THROUGH BILATERAL SAPHENOUS VEIN ACCESS, THE DEVICE ALLEGEDLY DID NOT RELEASE FROM THE SYSTEM BECAUSE IT REMAINED ATTACHED TO THE BLUE STENT BRAKE. THE USER ROTATED THE SYSTEM FOR COMPLETE EXPANSION; UPON REMOVAL THE SYSTEM GOT STUCK ON THE TIP WHICH LED TO STENT KINK AT THE DISTAL END. BALLOON DILATION WAS PERFORMED TO FULLY OPEN THE STENT BUT THE STENT END REMAINED BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085793 ↗
• MalfunctionNov 26, 2020Entrapment of Device; Activation Failure; Entrapment of Device; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE,CATHETER ALLEGEDLY STUCK ON STENT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS ABLE TO REMOVE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910949 ↗
• MalfunctionNov 20, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A BILATERAL VENOUS STENT PLACEMENT, THE STENT FAILED TO EXPAND IN THE LEFT ILIAC VEIN AS THE DEPLOYMENT SYSTEM WOULD NOT LET GO THE STENT. AS REPORTED THE STENT FINALLY EXPANDED FROM THE SYSTEM AFTER SLIGHTLY TURNING 2-5 MINUTES ON THE SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10873364 ↗