Venovo® VENUM16060Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741103568), received between Jul 12, 2019 and Sep 15, 2026 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Failure to Advance; Material Deformation

  On (b)(6) 2026, A patient underwent a stent placement procedure using Venovo Stent via right femoral vein. Prior to the procedure, the stent could not be advanced over the guidewire. The procedure was completed using another device. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767711 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON JUNE 30, 2025, IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE USING VENOVO VENOUS STENT, THE DEPLOYMENT SYSTEM ALLEGEDLY DISCONNECTED FROM THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640136 ↗
• MalfunctionDec 30, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA GROIN ACCESS, THE STENT ALLEGEDLY JUMPED. IT WAS FURTHER REPORTED THAT A SNARE DEVICE WAS USED TO PULL BACK THE STENT. REPORTEDLY, ANOTHER STENT WAS USED TO KEEP THE STENT IN PLACE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21033135 ↗
• MalfunctionDec 28, 2023Entrapment of Device; Fracture; Material Deformation; Entrapment of Device; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY FOUND TO BE FRACTURED UPON POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. REPORTEDLY, AN ADDITIONAL STENT WAS PLACED WITHIN THE FRACTURED AREA OF THE PREVIOUS STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408949 ↗
• InjuryApr 20, 2022Migration or Expulsion of Device; Difficult to Remove; Obstruction of Flow; Migration or Expulsion of Device; Difficult to Remove; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY TEN DAYS POST STENT PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY MIGRATED FROM THE COMMON ILIAC ARTERY TO THE VENA CAVA. IT WAS FURTHER REPORTED THAT A BLOOD CLOT WAS IDENTIFIED AND REMOVED. REPORTEDLY, THE DEVICE WAS UNABLE TO BE REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 14155628 ↗
• MalfunctionMay 14, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY FAILURE TO EXPAND . THERE WAS REPORTED NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824803 ↗
• MalfunctionJul 12, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT POST STENT PLACEMENT AT THE BIFURCATION, THE STENT ALLEGEDLY BECAME STUCK ON ANOTHER STENT. ADDITIONAL STENTS WERE IMPLANTED TO OPEN THE AREA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8786278 ↗