Venovo® VENUM12120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741103315), received between Dec 9, 2020 and Jun 25, 2021 — classified as 3 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-1898-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE IN THE ILIAC VEIN THROUGH THE CEPHALIC FEMORAL VEIN, THE DEVICE ALLEGEDLY FAILED TO EXPAND. THE DEVICE WAS THEN REPORTED TO HAVE OPENED UP AFTER A FEW MINUTES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065693 ↗
• MalfunctionMar 4, 2021Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT CEPHALIC FEMORAL VEIN, THE STENT ALLEGEDLY FAILED TO BE DEPLOYED AT THE PROXIMAL END. IT WAS FURTHER REPORTED THAT AFTER FURTHER ROTATION OF THE HANDLE, THE STENT WAS RELEASED WITHOUT ANY FURTHER COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11411196 ↗
• MalfunctionDec 9, 2020Break; Detachment of Device or Device Component; Activation Failure; Break; Detachment of Device or Device Component; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIOFEMORAL VEINS VIA IPSILATERAL APPROACH, THE STENT ALLEGEDLY FAILED TO EXPAND AS IT DID NOT DETACH FROM THE CATHETER. IT WAS FURTHER REPORTED THAT THE TIP OF THE DELIVERY SYSTEM ALLEGEDLY DETACHED AND STUCK TO THE GUIDEWIRE. REPORTEDLY, THE STENT FINALLY DETACHED FROM THE CATHETER AND FINISHED EXPANDING UPON REMOVAL; THE DETACHED TIP WAS REMOVED WITH THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10973768 ↗