Venovo® VENUM14100Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741103445), received between Nov 18, 2020 and Oct 8, 2025 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (26 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2025Fracture; Fracture

  A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE VENOVO VENOUS STENT. POST PROCEDURE, ON (B)(6) 2025 DURING AN EMBOLIZATION PROCEDURE, THEY ALLEGEDLY FOUND OUT THAT THE STRUTS ARE BROKEN OFF FROM THE VENOVO STENT WHICH WAS PLACED A YEAR AGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23243989 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STENT PLACEMENT USING THE VENOVO STENT. POST PROCEDURE THE PATIENT ALLEGEDLY EXPERIENCED NICKEL ALLERGY. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22910676 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST A STENT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INTERMITTENT SWELLING IN LEFT LEG. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20234976 ↗
• MalfunctionOct 25, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE FOR ILIAC VENOUS OCCLUSIVE DISEASE WITH POPLITEAL ACCESS, THE STENT ALLEGEDLY FAILED TO FULLY EXPAND. REPORTEDLY, 80% OF THE STENT DEPLOYED THEN A SEGMENT REMAINED CONSTRAINED TO THE CATHETER AND THEN THE REMAINING PORTION DEPLOYED. REPORTEDLY, THE USER WAITED FIVE MINUTES THEN THE STENT FULLY EXPANDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694967 ↗
• MalfunctionJun 7, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11944864 ↗
• MalfunctionMay 21, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861878 ↗
• MalfunctionMay 20, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE STENT FINALLY EXPANDED AFTER TWISTING THE HANDLE BACK AND FORTH A FEW TIMES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854221 ↗
• MalfunctionMay 5, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY HAD AN EXPANSION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776117 ↗
• MalfunctionMay 5, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775521 ↗
• MalfunctionMay 5, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775517 ↗
• MalfunctionApr 27, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT DID NOT FULLY EXPAND. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730452 ↗
• MalfunctionApr 26, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722903 ↗
• 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 11705070 ↗
• MalfunctionApr 20, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH LEFT COMMON FEMORAL VESSEL, THE DEVICE ALLEGEDLY FAILED TO EXPAND IN THE PROXIMAL PORTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692378 ↗
• MalfunctionApr 20, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691676 ↗
• MalfunctionApr 12, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT BRACHIAL CEPHALIC, THE STENT ALLEGEDLY HAD EXPANSION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11647307 ↗
• MalfunctionApr 9, 2021Positioning Failure; Material Deformation; Activation Failure; Positioning Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC VEIN THROUGH THE FEMORAL VEIN, THE PROXIMAL END OF THE STENT ALLEGEDLY DID NOT DEPLOY AND WAS STUCK ON THE CATHETER. IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE CATHETER, THE STENT MOVED SEVERAL MILLIMETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641554 ↗
• MalfunctionMar 31, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT THE PROXIMAL END OF THE STENT ALLEGEDLY HAD EXPANSION ISSUE. THE STENT WAS RELEASED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594169 ↗
• MalfunctionMar 15, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479822 ↗
• MalfunctionMar 15, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE ILIAC VEINS, THE DEVICE ALLEGEDLY FAILED TO EXPAND IN THE PROXIMAL END AS IT WAS STUCK TO THE INNER CATHETER. IT WAS FURTHER REPORTED THAT THE USER WAITED 30 SECONDS AND THEN ROTATED THE HANDLE TO RELEASE THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11479148 ↗
• MalfunctionMar 12, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND ON PROXIMAL END. IT WAS FURTHER REPORTED STENT DEPLOYED SUCCESSFULLY BY ROTATING HANDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473154 ↗
• MalfunctionMar 4, 2021Loss of or Failure to Bond; Positioning Failure; Malposition of Device; Activation Failure; Loss of or Failure to Bond; Positioning Failure; Malposition of Device; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DID NOT DEPLOY FULLY AND STUCK ON THE PROXIMAL PORTION. FURTHER REPORTED THAT THE PHYSICIAN REMOVED THE RETRACTING CATHETER FROM THE BODY, THE STENT JUMPED FORWARD ABOUT 2 CMS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408713 ↗
• MalfunctionFeb 12, 2021Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH THE LEFT COMMON FEMORAL VEIN, THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ROTATED COUNTER CLOCKWISE 3 TIMES BEFORE THE STENT WAS RELEASED. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320171 ↗
• MalfunctionFeb 2, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11264467 ↗
• MalfunctionJan 12, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH RIGHT POPLITEAL, THE DEVICE ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT FEW MINUTES LATER THE STENT WAS SUCCESSFULLY RELEASED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11152981 ↗