Venovo® VENUM12100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741103308), received between Dec 1, 2020 and Jan 6, 2026 — classified as 5 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-1898-2021 · 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.

• MalfunctionJan 6, 2026Misfire

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING VENOVO STENT VIA RIGHT FEMORAL VEIN. DURING THE PROCEDURE, IT WAS REPORTED THAT THE LARGE WHEEL BECAME LOOSE AFTER UNLOCKING THE RED LOCK, PREVENTING FULL STENT DEPLOYMENT. THE PHYSICIAN DISASSEMBLED THE DELIVERY HANDLE AND USED THE REMAINING INTACT PIECE TO DEPLOY THE STENT; THE CATHETER WAS MANIPULATED AND PULLED TOWARD THE WIRE TO COMPLETE DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23971438 ↗
• MalfunctionMay 27, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE IN THE ILIAC VEINS WITH FEMORAL ACCESS, THE STENT WAS ALLEGEDLY FAILED TO EXPAND AS THE PROXIMAL END OF THE STENT WAS STUCK TO THE INNER CATHETER. REPORTEDLY, THE STENT WAS STUCK A SPLIT SECOND THEN FULLY EXPANDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891818 ↗
• MalfunctionMay 25, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11874894 ↗
• MalfunctionDec 4, 2020Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING TREATMENT IN THE INFERIOR VENA CAVA, THE STENT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT, THE DEVICE ALLEGEDLY HAD AN EXPANSION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10947658 ↗
• MalfunctionDec 1, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY HAD FORESHORTENING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10926135 ↗