Venovo® VENUM18120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741103735), received between Mar 4, 2021 and Mar 3, 2026 — classified as 6 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-1897-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break; Positioning Failure; Melted

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE VENOVO VENOUS STENT. DURING THE PROCEDURE, THE DEVICE WAS INSERTED. ONCE IT WAS TIME TO DEPLOY THE STENT, IT WAS NOTICED THAT THE UNLOCK BUTTON WAS BROKEN. FURTHERMORE, IT WAS REPORTED THAT THE BUTTON WAS UNABLE TO CLICK. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492921 ↗
• MalfunctionMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A STENT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED GENERAL FATIGUE AND PAIN IN UPPER LEGS, LOWER LEGS AND TOP OF THE FEET. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18920284 ↗
• MalfunctionFeb 23, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE PROXIMAL END OF THE STENT ALLEGEDLY DID NOT FULLY DETACH FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT EVEN AFTER ONE MINUTE, THE STENT ALLEGEDLY DID NOT RELEASE. REPORTEDLY THE PHYSICIAN ROTATED THE DEPLOYMENT HANDLE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765752 ↗
• MalfunctionJun 2, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT STENT WAS DEPLOYED AFTER FIVE MINUTES BY ROTATING CATHETER HANDLE IN CLOCKWISE DIRECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918590 ↗
• MalfunctionMar 31, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT IN THE ILIAC VEIN THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO OPEN. THE USER ROTATED THE HANDLE AND THE STENT EXPANDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594144 ↗
• MalfunctionMar 4, 2021Entrapment of Device; Activation Failure; Entrapment of Device; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS FAILED TO EXPAND FULLY AND WHEN THE PHYSICIAN TRIED TO REMOVE THE SYSTEM FROM THE PATIENT, IT WAS STUCK AT THE PROXIMAL END OF THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11410797 ↗