Venovo® VENUL14080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741103506), received between Dec 11, 2020 and Jun 6, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (7 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-1899-2021 · 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.

• MalfunctionJun 6, 2022Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600028 ↗
• MalfunctionFeb 24, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE DOCTOR TWISTED AND MANIPULATED THE DEVICE TO GET IT RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371800 ↗
• MalfunctionJan 28, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242477 ↗
• MalfunctionJan 18, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11184262 ↗
• MalfunctionJan 11, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH THE COMMON FEMORAL VEIN, THE STENT ALLEGEDLY WAS STUCK ON THE CATHETER AND IT TOOK 2 TO 3 MINS TO RELEASE FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146371 ↗
• MalfunctionJan 11, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WAS STUCK ON THE CATHETER, AND IT TOOK 2 TO 3 MINS TO RELEASE FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11145300 ↗
• MalfunctionDec 11, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WAS DIFFICULT TO DEPLOY. IT WAS FURTHER REPORTED THAT THE STENT WAS SUCCESSFULLY DEPLOYED AFTER DEVICE WAS DISASSEMBLED AND STENT POST DILATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991459 ↗