Venovo® VENUL14140Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741103537), received between Nov 13, 2019 and May 6, 2021 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782757 ↗
• MalfunctionApr 1, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DISTAL PORTION OF STENT DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT AFTER 3 MINUTES STENT FULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600928 ↗
• MalfunctionMar 29, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580640 ↗
• MalfunctionMar 3, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE LEFT ILIAC VEIN VIA BILATERAL FEMORAL APPROACH, THE PART OF THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE USER HAVE TWISTED THE CATHETER SYSTEM TO FINALLY EXPAND THE STENT. THE ALLEGED EXPANSION FAILURE LED TO A PROLONGED PROCEDURE; HOWEVER, THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404139 ↗
• MalfunctionMar 2, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE, THE STENT DISTAL END ALLEGEDLY HAD DIFFICULTY TO DEPLOY. IT WAS FURTHER REPORTED THAT STENT WAS STUCK WITH DELIVERY SYSTEM AND RELEASED AFTER FEW MINUTES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11397605 ↗
• MalfunctionFeb 16, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330972 ↗
• MalfunctionJan 13, 2021Break; Activation Failure; Break; 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 11160175 ↗
• MalfunctionDec 29, 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 11086660 ↗
• MalfunctionDec 29, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CRIMPED AT THE END OF THE STENT AND WAS STILL ADHERED TO THE CATHETER. IT WAS FURTHER REPORTED THAT THE STENT WAS RELEASED AFTER 15-20 SECONDS AND DEPLOYED AS NORMAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085935 ↗
• MalfunctionDec 17, 2020Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH RIGHT COMMON ILIAC VEIN, THE DEVICE ALLEGEDLY HAD DIFFICULTY TO DEPLOY AND FAILED TO EXPAND IN THE DISTAL PORTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11026734 ↗
• MalfunctionDec 17, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE STENT END DID NOT CORRECTLY EXPAND DURING DEPLOYMENT. THE STENT FINALLY DEPLOYED BY TWISTING THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11026645 ↗
• MalfunctionDec 14, 2020Activation 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 11002293 ↗
• MalfunctionDec 10, 2020Entrapment of Device; Activation Failure; Entrapment of Device; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY STUCK TO DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT AFTER SHAKING AND TWISTING CATHETER THE STENT FINALLY DEPLOYED BUT ALLEGEDLY FAILED TO EXPAND. REPORTEDLY, THE GUIDEWIRE ALLEGEDLY GOT STUCK TO THE STENT STRUT. THE PROCEDURE WAS COMPLETED WITH EXPANSION OF THE STRUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10981448 ↗
• MalfunctionDec 7, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A BILATERAL STENT PLACEMENT PROCEDURE IN THE ILIAC VEINS, THE STENT ALLEGEDLY DID NOT OPEN IN ONE AREA AFTER THE STENT SHEATH HAD BEEN RETRACTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10957517 ↗
• MalfunctionNov 25, 2020Misfire; Activation Failure; Misfire; Activation Failure

  IT WAS REPORTED THAT DURING TREATMENT, THE STENT ALLEGEDLY HAD A PARTIAL DEPLOYMENT INSIDE THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10902142 ↗
• MalfunctionNov 20, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT WAS GETTING CAUGHT ON THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874371 ↗
• MalfunctionNov 19, 2020Difficult to Remove; Misfire; Activation Failure; Difficult to Remove; Misfire; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE ILIOFEMORAL VEINS THROUGH POPLITEAL ACCESS, THE DEVICE ALLEGEDLY DEPLOYED PARTIALLY AND DIFFICULT TO REMOVE AS IT WAS STUCK TO THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10865861 ↗
• MalfunctionNov 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING TREATMENT OF THE LEFT COMMON ILIAC AND LEFT EXTERNAL ILIAC VEIN VIA GREAT SAPHENOUS VEIN, AFTER THE STENT HAD BEGUN TO DEPLOY, THE HEALTHCARE PROVIDER (HCP) REALIZED THAT THE STENT SHOULD BE PLACED LOWER AND ATTEMPTED TO MOVE THE STENT TO THE DESIRED LOCATION; HOWEVER, THE MOVEMENT CAUSED THE STENT TO ALLEGEDLY FRACTURE INTO TWO SEGMENTS. THEREFORE, THE STENT WAS COMPLETELY DEPLOYED IN THE EXTERNAL ILIAC AND COMMON FEMORAL VEIN. IT WAS FURTHER REPORTED THAT A PTA BALLOON AND AN ADDITIONAL STENT OF A DIFFERENT SIZE WERE USED TO COVER THE ENTIRETY OF THE LESION, COMPLETING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9317452 ↗