Zilver Vena G57443Recalls & reported problems
Cook Ireland Ltd · Zilver Vena, Venous Self-Expanding Stent · Class 3 · Implant
All models of Zilver Vena (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002574431), received between Oct 11, 2021 and May 8, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (2 reports).
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.
Most reported problems
Device problems
- Use of Device Problem2
- Break1
- Improper or Incorrect Procedure or Method1
- No Apparent Adverse Event1
- Structural Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-JUL-2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16885456 ↗MalfunctionOct 11, 2021Break; Use of Device Problem; Structural Problem; No Apparent Adverse Event; Break; Use of Device Problem; Structural Problem; No Apparent Adverse Event
SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO CONFIRMATION OF USER ERROR ON 26-MAY-2022. AS PER IFU00091, ¿HOLD THE HUB ON THE METAL CANNULA STEADY. TO INITIATE DEPLOYMENT OF THE STENT, REMOVE THE RED SAFETY LOCK". A PER THE COMPLAINT DESCRIPTION: ¿INARI SHEATH GRIPPED ON THE OUTER SHAFT OF THE STENT, AND CAUSED THE SEPARATION OF THE OUTER SHEATH.¿ ANNEX A AND G CODES UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12606076 ↗
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
- 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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