Venovo® VENUM16140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741103605), received between Oct 15, 2019 and Sep 6, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT EXTERNAL ILIAC VEIN VIA LEFT FEMORAL VEIN, THE STENT WAS ALLEGEDLY STICKING TO THE INNER CATHETER STENT BREAK FOR THREE MINUTES. IT WAS FURTHER REPORTED THAT THE STENT WAS FINALLY RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17688913 ↗
• MalfunctionMay 24, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, WHEN TRYING TO REMOVE THE DELIVERY SYSTEM IT WAS ALLEGEDLY PULLING ON THE STENT. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY DISCONNECTED BY PUSHING THE DELIVERY SYSTEM FORWARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993694 ↗
• MalfunctionJul 2, 2021Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY TOO LONG FOR THE LESION TO BE PLACED. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT DEPLOYED AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107742 ↗
• MalfunctionApr 27, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PROXIMAL END OF STENT STAYED STUCK ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730427 ↗
• MalfunctionOct 15, 2019Entrapment of Device; Retraction Problem; Entrapment of Device; Retraction Problem

  IT WAS REPORTED THAT AFTER STENT DEPLOYMENT IN THE COMMON ILIAC VEIN VIA COMMON FEMORAL VEIN ACCESS, THE DELIVERY SYSTEM WAS ALLEGEDLY CAUGHT ON THE INTRODUCER SHEATH DURING RETRACTION. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM AND INTRODUCER SHEATH WERE REMOVED TOGETHER AS ONE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195154 ↗