Venovo® VENUM14160Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741103476), received between Sep 17, 2020 and Apr 7, 2025 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (25 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2025Difficult or Delayed Positioning; Malposition of Device; Material Deformation; Difficult or Delayed Positioning; Malposition of Device; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA GROIN IPSILATERAL, THE STENT ALLEGEDLY HAD DIFFICULTY IN ROLLER WHEEL DEPLOYMENT AFTER POSITIONING. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY FORESHORTENED DURING PLACEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21793805 ↗
• MalfunctionMay 27, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN STENOSIS VIA SAPHENOUS VEIN, THE DISTAL END OF THE STENT ALLEGEDLY DID NOT OPEN FULLY. IT WAS FURTHER REPORTED THAT THE PROXIMAL SEGMENT WHERE THE STENT LANDED WAS ALLEGEDLY MEASURING LARGER THAN THE DISTAL SEGMENT. REPORTEDLY, A BALLOON WAS USED TO EXPAND THE DISTAL PART OF THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399411 ↗
• MalfunctionJun 2, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE EXTERNAL ILIAC VEIN VIA POPLITEAL VEIN, ONE OF THE LEG OF THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE STENT WAS ABLE TO EXPAND AFTER SOME MANEUVERS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048751 ↗
• MalfunctionJun 2, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN EXTERNAL ILIAC VEIN VIA POPLITEAL ACCESS, ONE OF THE LEG OF THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE STENT WAS ABLE TO EXPAND AFTER SOME MANEUVERS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048666 ↗
• InjuryAug 17, 2021Entrapment of Device; Nonstandard Device; Migration

  VENOVO STENT PLACED ON (B)(6) 2020 IN FACILITY "A". ON (B)(6) 2020: PATIENT IN ED C/O SOB. DISCHARGED AND READMITTED ON (B)(6) 2020 WITH SOB AND CHEST PAIN. CT OF ABDOMEN AND PELVIS REPORTED IN BODY OF NOTE "PARTIALLY IMAGED STENT IN THE RIGHT ATRIUM." HOWEVER, THIS WAS NOT INDICATED UNDER IMPRESSION / FINDINGS. PATIENT WAS DISCHARGED ASYMPTOMATIC FOR SEVERAL MONTHS. EXPERIENCED SOB AND CHEST PAIN ON AND OFF FOR SEVERAL WEEKS. A 2D ECHOCARDIOGRAM ON (B)(6) 2021 FOR CHF REVEALED STENT IN THE RIGHT ATRIUM. MIGRATION OF THE STENT CONFIRMED BY FLUOROSCOPY ON (B)(6) 2021. ADMITTED TO "FACILITY B" ON (B)(6) 2021 FOR STENT REMOVAL. STENT REMOVED ON (B)(6) 2021. PER OPERATIVE REPORT, THE STENT EXTENDED INTO THE SVC AND IVC AND WAS EMBEDDED IN THE CARDIAC TISSUE. THE DEVICE WAS EXTRACTED IN MULTIPLE PIECES. REMAINING STENT EXTRACTED IN SEGMENTS AFTER DISSECTION FROM THE INTRACARDIAC TISSUE. PATIENT WAS ADMITTED TO CICU POST OP. AFTER A HOSPITAL AND SKILLED NURSING STAY, PATIENT WAS DISCHARGE ON (B)(6) 2021. AS HIS PRIMARY CARE GIVER, IT IS UNKNOWN IF THIS EVENT WAS REPORTED. LEARNED TODAY THAT MANUFACTURER RECALLED THE STENT THAT WAS PLACED IN PATIENT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Chest Pain; Device Embedded In Tissue or Plaque; Dyspnea

  MAUDE report 12336943 ↗
• MalfunctionJun 25, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT PROCEDURE THROUGH THE CEPHALIC FEMORAL VEIN, THE STENT 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 12065779 ↗
• MalfunctionJun 3, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE PROXIMAL END OF THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT STENT WAS OPENED 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 11929930 ↗
• MalfunctionMay 18, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO EXPAND AT THE DISTAL END. IT WAS FURTHER REPORTED THAT THE HANDLE WAS TWISTED TO DEPLOY THE STENT COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11839578 ↗
• MalfunctionMay 14, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING SENT DEPLOYMENT PROCEDURE, THE STENT ALLEGEDLY HAD AN EXPANSION ISSUE. IT WAS FURTHER REPORTED THAT THE STENT WAS EXPANDED AFTER COUPLES MINUTES BY MANIPULATING THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824666 ↗
• MalfunctionMay 5, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE BILATERAL COMMON, THE STENT ALLEGEDLY FAILED TO EXPAND AT DISTAL END. IT WAS FURTHER REPORTED THAT THE DEPLOYMENT CATHETER WAS ALLEGEDLY DIFFICULT TO REMOVE AFTER DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775342 ↗
• MalfunctionMay 5, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE BILATERAL COMMON AND EXTERNAL ILIAC VEIN, THE STENT ALLEGEDLY FAILED TO EXPAND AT DISTAL END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11775315 ↗
• MalfunctionApr 22, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11705184 ↗
• MalfunctionMar 31, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT IN THE ILIAC VEIN THE PROXIMAL END OF THE STENT ALLEGEDLY HAD EXPANSION ISSUE. REPORTEDLY, THE USER ROTATED THE HANDLE AND THE STENT WAS RELEASED AFTER 30 SECONDS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593980 ↗
• MalfunctionMar 12, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE PROXIMAL END OF STENT ALLEGEDLY HAD DIFFICULT TO RELEASE ABOUT FEW MINUTES. IT WAS FURTHER REPORTED AFTER FEW MINUTES IT GOT DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11472498 ↗
• MalfunctionMar 12, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT ON COMMON ILIAC VEINS TO COMMON FEMORAL VEINS, THE PROXIMAL END OF STENT ALLEGEDLY HAD DIFFICULT TO RELEASE ABOUT FEW MINUTES. IT WAS FURTHER REPORTED AFTER FEW MINUTES IT GOT DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11472285 ↗
• MalfunctionMar 5, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PROXIMAL PORTION OF THE STENT FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11420345 ↗
• MalfunctionFeb 22, 2021Activation Failure; Activation Failure

  IT WAS REPORTED, THAT DURING A STENT PLACEMENT PROCEDURE. THE DISTAL END OF THE STENT FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357309 ↗
• MalfunctionFeb 22, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DISTAL END OF THE STENT FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357061 ↗
• MalfunctionJan 28, 2021Entrapment of Device; Activation Failure; Entrapment of Device; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH THE LEFT POPLITEAL VEIN, THE LAST SEGMENT OF THE STENT WAS ALLEGEDLY REPORTED TO HAVE GOT CAUGHT. IT WAS FURTHER REPORTED THAT THE STENT DEPLOYED EVENTUALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242419 ↗
• MalfunctionDec 29, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT THROUGH EXTERNAL ILIAC AND COMMON FEMORAL VEIN, THE DEVICE ALLEGEDLY FAILED TO EXPAND IN THE PROXIMAL END. IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE STENT ELONGATED SLIGHTLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085677 ↗
• MalfunctionDec 24, 2020Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11070600 ↗
• MalfunctionDec 16, 2020Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT, THE DEVICE ALLEGEDLY HAD DIFFICULTY TO DEPLOY AND FAILED TO EXPAND IN THE DISTAL PART. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11017758 ↗
• MalfunctionDec 16, 2020Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT, THE DEVICE ALLEGEDLY HAD DIFFICULTY TO DEPLOY AND FAILED TO EXPAND IN THE DISTAL PART. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11017481 ↗
• MalfunctionDec 14, 2020Activation Failure; Activation Failure

  IT WAS REPORTED, THAT DURING STENT PLACEMENT PROCEDURE. THROUGH FEMORAL VEIN VIA IPSILATERAL RETROGRADE APPROACH, THE STENT ALLEGEDLY, FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11001055 ↗
• MalfunctionDec 14, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE THROUGH FEMORAL VEIN VIA IPSILATERAL RETROGRADE APPROACH, THE STENT ALLEGEDLY FAILED TO EXPAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11001053 ↗