Venovo® VENUL18120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741103803), received between Nov 5, 2020 and Mar 24, 2021 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2021Entrapment of Device; Device-Device Incompatibility; Material Deformation; Activation Failure; Entrapment of Device; Device-Device Incompatibility; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE CATHETER WAS STUCK ON THE WIRE AND THE SHEATH WAS DAMAGED AT THE TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559140 ↗
• MalfunctionNov 24, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT WAS GETTING CAUGHT ON THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10893387 ↗
• InjuryNov 5, 2020Entrapment of Device; Appropriate Device Problem Term/Code Not Available; Activation Failure; Entrapment of Device; Appropriate Device Problem Term/Code Not Available; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT THROUGH ILIAC VEIN, THE STENT ALLEGEDLY DID NOT DEPLOY CORRECTLY. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY STUCK IN THE ILIAC VEIN. REPORTEDLY MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE STENT. THE PATIENT CURRENT STATUS WAS NORMAL.

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

  MAUDE report 10789779 ↗