Venovo® VENUM14060Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741103421), received between Nov 20, 2020 and Oct 16, 2023 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (14 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 16, 2026.

Recalls naming this device

1. Dec 14, 2020Open, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST STENT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD MUSCLE SPASMS AND SCIATICA SINCE PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940091 ↗
• MalfunctionApr 21, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WILL NOT LET GO OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16789848 ↗
• 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 11911293 ↗
• MalfunctionApr 26, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722501 ↗
• MalfunctionApr 13, 2021Positioning Failure; Material Twisted/Bent; Activation Failure; Positioning Failure; Material Twisted/Bent; Activation Failure

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT PROCEDURE THROUGH RIGHT FEMORAL VEIN, THE STENT ALLEGEDLY FAILED TO DEPLOY AND BECAME TWISTED IN THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656232 ↗
• MalfunctionMar 15, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE THROUGH FEMORAL VEIN IN THE POST THROMBOTIC OCCLUDED LEFT ILIAC, THE STENT ALLEGEDLY HAD EXPANSION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11483296 ↗
• MalfunctionMar 9, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT, 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 11441589 ↗
• MalfunctionFeb 15, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326927 ↗
• MalfunctionJan 19, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE THROUGH POPLITEAL ACCESS IN THE RIGHT COMMON TO COMMON FEMORAL, THE STENT ALLEGEDLY FAILED TO EXPAND AT THE DISTAL END. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11192394 ↗
• MalfunctionJan 12, 2021Activation Failure; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153031 ↗
• MalfunctionJan 7, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DID NOT DEPLOY CORRECTLY. IT WAS FURTHER REPORTED THAT THE STENTS WERE TWISTED CLOCKWISE AND COUNTER CLOCKWISE TO GET THEM DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11130592 ↗
• MalfunctionJan 7, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DID NOT DEPLOY CORRECTLY. IT WAS FURTHER REPORTED THAT THE STENTS WERE TWISTED CLOCKWISE AND COUNTER CLOCKWISE TO GET THEM DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11130483 ↗
• MalfunctionDec 29, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE RIGHT ILIAC VEIN THROUGH IPSILATERAL POPLITEAL ACCESS, THE TAIL END OF THE STENT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE PHYSICIAN JIGGLED THE SYSTEM TO FINALLY DEPLOY THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11086709 ↗
• MalfunctionDec 28, 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 11075206 ↗
• MalfunctionNov 20, 2020Misfire; Malposition of Device; Activation Failure; Misfire; Malposition of Device; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT IN THE ILIAC VEIN THE STENT ALLEGEDLY WAS STUCK TO THE DEPLOYMENT SYSTEM AFTER RELEASE LEADING TO EXPANSION ISSUE AND MALPOSITION. THE STENT FINALLY SUCCESSFULLY EXPANDED AFTER A FEW MINUTES BY PULLING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10873398 ↗