Venovo® VENUL16160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741103681), received between Sep 14, 2020 and Feb 22, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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-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.

• MalfunctionFeb 22, 2021Malposition of Device; Material Twisted/Bent; Activation Failure; Malposition of Device; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH FEMORAL VEIN, THE DEVICE ALLEGEDLY FAILED TO EXPAND AND MALPOSITIONED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358099 ↗
• MalfunctionJan 13, 2021Misfire; Material Deformation; Misfire; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11160939 ↗
• InjurySep 14, 2020Entrapment of Device; Fracture; Migration or Expulsion of Device; Entrapment of Device; Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN RIGHT ILIAC VEIN FOR BILATERAL VENOUS COMPRESSION VIA RIGHT INTERNAL JUGULAR VEIN APPROACH, THE STENT ALLEGEDLY BROKE AND MIGRATED TO THE HEART. CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10526696 ↗
• InjurySep 14, 2020Entrapment of Device; Fracture; Material Deformation; Entrapment of Device; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT ILIAC VEIN VIA RIGHT INTERNAL JUGULAR VEIN APPROACH, THE STENT ALLEGEDLY FRACTURED AND MANGLED. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 10526679 ↗