Venovo® VENUL18140Recalls & reported problems
Angiomed GmbH & Co. Medizintechnik KG · Venovo® Venous Stent System 18 mm x 140 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741103810), received between Jul 2, 2026 and Jul 2, 2026 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Burning Sensation2
- Shaking/Tremors2
- Superficial (First Degree) Burn2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A SENT PLACEMENT PROCEDURE USING THE VENOVO STENT. DURING AN MRI SCAN, APPROXIMATELY 15 TO 20 MINUTES INTO THE PROCEDURE, THE PATIENT EXPERIENCED A HOT, BURNING SENSATION IN HER BACK AND NOTIFIED THE TECHNICIAN. THE SCAN WAS CONTINUED AT THE PATIENTS PREFERENCE, DESPITE HER REQUEST FOR A BLOOD PRESSURE CHECK, WHICH WAS NOT PERFORMED. AFTER APPROXIMATELY 40 MINUTES, SHE EXPERIENCED BACK QUIVERING ALONG WITH PERSISTENT BURNING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Burning Sensation; Shaking/Tremors; Superficial (First Degree) Burn
MAUDE report 25690349 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A SENT PLACEMENT PROCEDURE USING THE VENOVO STENT. DURING AN MRI SCAN, APPROXIMATELY 15 TO 20 MINUTES INTO THE PROCEDURE, THE PATIENT EXPERIENCED A HOT, BURNING SENSATION IN HER BACK AND NOTIFIED THE TECHNICIAN. THE SCAN WAS CONTINUED AT THE PATIENTS PREFERENCE, DESPITE HER REQUEST FOR A BLOOD PRESSURE CHECK, WHICH WAS NOT PERFORMED. AFTER APPROXIMATELY 40 MINUTES, SHE EXPERIENCED BACK QUIVERING ALONG WITH PERSISTENT BURNING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Burning Sensation; Shaking/Tremors; Superficial (First Degree) Burn
MAUDE report 25690336 ↗
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.
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