Venovo® VENUM14080Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741103438), received between Sep 22, 2020 and Jun 24, 2025 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (33 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Break; Fracture; Detachment of Device or Device Component; Migration; Break; Fracture; Detachment of Device or Device Component; Migration

  ON (B)(6) 2024, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A VENOVO VENOUS STENT. IN (B)(6) 2024, A SCOUT SCAN AND CT ALLEGEDLY IDENTIFIED A STENT FRACTURE AT THE LEVEL OF THE INITIAL STENOSIS AND NOTICED A WATERMELON SEED TYPE MIGRATION TOWARDS THE RIGHT ATRIUM. PATIENT PRESENTED TO THE HOSPITAL WITH A CYSTIC FIBROSIS EXACERBATION AND HAD A CHEST X-RAY PERFORMED. THE STENT WAS OBSERVED TO HAVE A LARGE FRACTURE. A CHEST CT WAS PERFORMED TO VISUALIZE THE FRACTURE. CURRENT PLAN IS TO TRY AND RETRIEVE THE STENT VIA IJ ACCESS AND PULL THE STENT OFF THE WALL AND UP TO THE IJ. CV SURGERY WILL ASSIST TO PROVIDE A VESSEL CUT DOWN TO RETRIEVE THE STENT. IF UNSUCCESSFUL CV SURGERY WILL RETRIEVE VIA OPEN CHEST. ACCORDING TO REPORTS, THE PATIENT EXPERIENCED AN EXACERBATION OF CYSTIC FIBROSIS. TO REMOVE THE FRACTURED STENT, VESSEL CUT-DOWN SURGERY WAS PERFORMED.

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

  MAUDE report 22318404 ↗
• MalfunctionDec 29, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY JUMPED INTO THE INFERIOR VENA CAVA. IT WAS FURTHER REPORTED THAT A SNARE DEVICE WAS USED TO PULL BACK THE STENT. REPORTEDLY, ANOTHER STENT WAS USED TO KEEP THE STENT IN PLACE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032782 ↗
• MalfunctionDec 9, 2021Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING TREATMENT THE STENT ALLEGEDLY WAS DIFFICULT TO DEPLOY AND FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE STENT OPENED AFTER 30 SECONDS WITHOUT COMPLICATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12966299 ↗
• MalfunctionDec 9, 2021Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE ON RIGHT GROIN, THE STENT ALLEGEDLY HAD DIFFICULTY TO DEPLOY AND EXPANSION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12966187 ↗
• MalfunctionJun 1, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11911294 ↗
• MalfunctionMay 27, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893459 ↗
• MalfunctionMay 27, 2021Activation Failure; Activation Failure

  IT WAS REPORTED DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD AN EXPANSION ISSUE. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893389 ↗
• MalfunctionMay 27, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN 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 USER DID NOT WANT TO WAIT LONGER THAN FOUR MINUTES, SO THE SYSTEM WAS TORN APART AND THE STENT WAS EXPANDED BY PUSHING THE SHEATH FORWARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891901 ↗
• MalfunctionMay 24, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT COMMON ILIAC THROUGH THE POPLITEAL VEIN, THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO DEPLOY AND EXPAND. IT WAS REPORTED THAT THE DOCTOR ROTATED THE CATHETER SEVERAL MINUTES BEFORE THE STENT GOT RELEASED AND FULLY EXPANDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869196 ↗
• MalfunctionApr 22, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO EXPAND IN THE DISTAL END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11705657 ↗
• MalfunctionApr 22, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE STENT PROXIMAL END ALLEGEDLY CRIMPED. IT WAS FURTHER REPORTED THAT PHYSICIAN TURN DELIVERY SYSTEM AND WAIT AND IT GET DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11705021 ↗
• MalfunctionApr 22, 2021Activation Failure; Activation Failure

  IT WAS REPORTED DURING STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY HAD AN EXPANSION ISSUE. IT WAS FURTHER REPORTED THAT SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704926 ↗
• MalfunctionApr 21, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE THROUGH LEFT FEMORAL VEIN, THE STENT ALLEGEDLY FAILED TO EXPAND IN THE PROXIMAL END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699180 ↗
• MalfunctionApr 20, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE THROUGH ILIAC VEIN VIA POPLITEAL, THE MIDDLE SEGMENT OF THE STENT NOT FULLY EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693815 ↗
• MalfunctionApr 20, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING VENOVO STENT DEPLOYMENT PROCEDURE THROUGH ILIAC VEIN VIA COMMON FEMORAL ARTERY, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD EXPANSION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693709 ↗
• MalfunctionApr 19, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT ON BILATERAL ILIAC VIA BILATERAL POPLITEAL, THE STENT PROXIMAL END ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT STENT GOT DEPLOYED AFTER TWISTING THE DEPLOYMENT SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683865 ↗
• MalfunctionApr 19, 2021Malposition of Device; Activation Failure; Malposition of Device; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683795 ↗
• MalfunctionApr 15, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, TWO CMS OF THE STENT ALLEGEDLY WAS STUCK ON THE CATHETER AND DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT PHYSICIAN WAITED FOR ABOUT 25 MINS AND USED A WIRE AND BALLOON TO GET THE STENT DEPLOYED AND THE STENT WAS FURTHER POST DILATED WITH A BALLOON TO GET IT FULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11669851 ↗
• MalfunctionApr 13, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND IN THE DISTAL END. IT WAS FURTHER REPORTED THAT STENT WAS DEPLOYED AFTER 4 MINUTES AND LEFT FORM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654362 ↗
• MalfunctionApr 12, 2021Activation 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 RELEASE FROM THE INNER CATHETER. REPORTEDLY, THE USER WAITED 30 SECONDS THEN ROTATED THE HANDLE AND THE STENT RELEASED SUCCESSFULLY FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648114 ↗
• MalfunctionMar 31, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT AFTER 10 MINUTES OF MANIPULATION, THE STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595491 ↗
• MalfunctionMar 22, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11541918 ↗
• MalfunctionMar 17, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT AFTER 10 MINUTES OF MANIPULATION, THE STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11501344 ↗
• MalfunctionMar 1, 2021Fracture; Material Deformation; Activation Failure; Fracture; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY GOT STUCK ON THE CATHETER UPON DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE TECHNICIAN RIPPED OUT THE DEPLOYMENT SYSTEM CAUSING THE STENT TO FRACTURE. THE END OF THE STENT WAS NOTED TO PROTRUDE LATERAL AND WAS REALIGNED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395166 ↗
• MalfunctionFeb 25, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT AFTER ROTATION, THE STENT GOT RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377900 ↗