Venovo® VENUM16080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741103575), received between May 16, 2019 and Oct 28, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE EXPIRED DEVICE WAS ALLEGEDLY IMPLANTED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20548177 ↗
• 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 18765754 ↗
• MalfunctionJun 12, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC VEIN VIA POPLITEAL ACCESS, THE STENT ALLEGEDLY GOT STUCK ON THE PROXIMAL END. IT WAS FURTHER REPORTED THAT THE STENT WAS RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105510 ↗
• InjuryApr 4, 2023Migration or Expulsion of Device; Obstruction of Flow; Migration or Expulsion of Device; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST STENT PLACEMENT PROCEDURE, THE STENT HAD ALLEGEDLY SHIFTED AND HAD A CLOT WHICH CAUSED SOME OBSTRUCTION OF FLOW ISSUES. IT WAS FURTHER REPORTED THAT THE CLOT WAS REMOVED AND TWO ADDITIONAL STENTS WERE PLACED TO PREVENT THE PREVIOUS STENT FROM SHIFTING FURTHER AND RESTORING BLOOD FLOW. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Thrombosis/Thrombus

  MAUDE report 16676052 ↗
• MalfunctionFeb 20, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE IN LEFT COMMON ILIAC VEIN VIA FEMORAL ACCESS, THE STENT PROXIMAL END ALLEGEDLY WAS DIFFICULT TO DEPLOY. IT WAS FURTHER REPORTED THAT STENT STUCK TO CUSHION FOR SEVERAL MINUTES AND DIDN'T FULLY COME OFF OF CUSHION WITHOUT TWISTING THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404075 ↗
• MalfunctionMar 15, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE STENT PROXIMAL END ALLEGEDLY HAD DIFFICULT TO DEPLOY. IT WAS FURTHER REPORTED THAT STENT WAS DEPLOYED AFTER COUPLE OF RATIONS BY THE HANDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11482052 ↗
• MalfunctionFeb 24, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE PROXIMAL END OF STENT FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAITED AND ROTATED HANDLE AND STENT APPEARED TO RELEASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371328 ↗
• MalfunctionDec 14, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH COMMON ILIAC VESSEL, THE DEVICE ALLEGEDLY FAILED TO EXPAND IN THE DISTAL END. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11000958 ↗
• MalfunctionNov 19, 2019Break; Use of Device Problem; Misfire; Malposition of Device; Break; Use of Device Problem; Misfire; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE LEFT COMMON ILIAC VEIN VIA LEFT COMMON FEMORAL APPROACH, THE STENT ALLEGEDLY FAILED TO DEPLOY MORE THAN 50%. REPORTEDLY, A GLOVE WAS CAUGHT IN TRANSITION WHEN THE SECOND CATHETER WENT INTO THE THIRD CATHETER. IT WAS FURTHER REPORTED THAT A HEMOSTAT WAS USED TO OPEN THE DEVICE AND MANUALLY DEPLOY THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9344741 ↗
• InjuryMay 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT AT 24-MONTH FOLLOW-UP VISIT, INTIMAL HYPERPLASIA WAS IDENTIFIED VIA DUPLEX ULTRASOUND. NO ACTION IS BEING TAKEN AT THIS TIME.

  Patient problems: Injury; Intimal Dissection

  MAUDE report 8616584 ↗