Zilver Vena G57441Recalls & reported problems
Cook Ireland Ltd · Zilver Vena, Venous Self-Expanding Stent · Class 3 · Implant
All models of Zilver Vena (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002574417), received between Sep 24, 2022 and Sep 24, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
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.
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2022Off-Label Use; Off-Label Use
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A MALE PATIENT OF APPROXIMATELY 57 YEARS OLD UNDERWENT A PORTAL VEIN OCCLUSION PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57441, WAS USED. THE PHYSICIAN ACCESSED THE PORTAL VEIN AND WAS READY TO DEPLOY, PHYSICIAN PULLED BACK ON HUB TO ALIGN MARKERS. PHYSICIAN DECIDED TO RE-ALIGN AND DID SO USING THE PIN AND PULL TECHNIQUE. THE STENT WAS UNCOVERED AND FORE SHORTENED (BUNCHED UP) BY 20MM. AFTER THE STENT DEPLOYED THE PHYSICIAN MEASURED PER FLEURO MACHINE AND IT WAS JUST OVER 40MM. A BARD BARE METAL STENT WAS DEPLOYED INSIDE OF THE ZILVER AND COMPLETED THE PROCEDURE SUCCESSFULLY. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15475522 ↗
Other Stent, iliac vein devices
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- 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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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