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Venovo® VENUM18100Recalls & reported problems

Angiomed GmbH & Co. Medizintechnik KG · Venovo® Venous Stent System 18 mm x 100 mm (80 cm delivery catheter) · Class 3 · Implant

All models of Venovo (84)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741103728), received between Apr 5, 2021 and Dec 15, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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-1897-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Activation Failure2
  • Material Deformation2
  • Device Damaged Prior to Use1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 15, 2022Activation Failure; Activation Failure

    IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DEPLOYED IMPROPERLY. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15985633 ↗
  • MalfunctionJul 14, 2021Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT, THE DEVICE ALLEGEDLY BROKE WHEN OPENED THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12164791 ↗
  • MalfunctionApr 5, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

    IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT COMMON ILIAC VEIN THROUGH THE FEMORAL VEIN, THE STENT DELAYED IN OPENING AND THE CATHETER WAS STUCK ON THE STENT. IT WAS FURTHER REPORTED THAT THE STENT WAS DEPLOYED UPON ROTATING THE HANDLE MULTIPLE TIMES BUT THE STRUTS WERE SLIGHTLY MISALIGNED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11612346 ↗

Other Stent, iliac vein devices

All Stent, iliac vein devices →

Sources and updates

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