Venovo® VENUL16100Recalls & reported problems
Angiomed GmbH & Co. Medizintechnik KG · Venovo® Venous Stent System 16 mm x 100 mm (120 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 00801741103650), received between Apr 7, 2021 and Dec 23, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (3 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.
Reports received per month
Recalls naming this device
- 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 Failure3
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 23, 2024Activation Failure; Activation Failure
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, ONE OF THE TOP STRUTS OF A STENT ALLEGEDLY DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT THE STRUTS WERE EXPANDING THROUGH BALLOON EXPANSION. REPORTEDLY, THE SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20998737 ↗MalfunctionSep 6, 2021Activation Failure; Activation Failure
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DISTAL THIRD OF THE STENT DEPLOYED; HOWEVER, THE HEALTHCARE PROFESSIONAL HAD TO USE A SEPARATE GUIDE WIRE AND BALLOON TO COMPLETE EXPANSION AND TO GET THE STENT DETACHED FROM THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12428284 ↗MalfunctionApr 7, 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 11625900 ↗
Other Stent, iliac vein devices
- Abre™ AB9U14080090Medtronic, Inc. · Stent, iliac vein2 recalls9 reports
- Venovo® VENUM16100Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall55 reports
- Venovo® VENUM14080Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall36 reports
- Venovo® VENUM14120Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall33 reports
- Venovo® VENUM14140Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall31 reports
- Venovo® VENUM14100Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall30 reports
- Venovo® VENUM16120Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall29 reports
- Venovo® VENUM14160Angiomed GmbH & Co. Medizintechnik KG · Stent, iliac vein1 recall27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page