Gianturco-Rosch Cook-Z G08553Recalls & reported problems
Cook Incorporated · Cook-Z Stent Gianturco-Rosch Tracheobronchial Design · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002085534), received between Apr 8, 2022 and Apr 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionApr 8, 2022Break; Break
AS REPORTED, A COOK-Z GIANTURCO-ROSCH TRACHEOBRONCHIAL STENT FRACTURED IN THE INFERIOR VENA CAVA (IVC). THE PROCEDURE INVOLVED RETRIEVAL OF A CELECT PLATINUM IVC FILTER, THROMBECTOMY OF THE IVC AND BILATERAL ILIAC VEINS, PLACEMENT OF KISSING ILIAC VEIN STENTS, AND PLACEMENT OF STENTS WITHIN THE IVC. A VENOUS THROMBECTOMY WAS PERFORMED IN THE LEFT ILIAC VEIN AND IVC, JUST BELOW THE FILTER. BILATERAL ACCESS WAS OBTAINED, AND A THROMBECTOMY WAS PERFORMED ON THE RIGHT SIDE. RIGHT JUGULAR ACCESS WAS THEN OBTAINED, AND THE IVC FILTER WAS RETRIEVED, USING A LOOP-TECHNIQUE WITH A 16 FRENCH SHEATH. A THROMBECTOMY OF THE IVC WAS THEN PERFORMED. DESPITE REPEATED ADVISEMENT BY A COOK REPRESENTATIVE THAT THE DEVICE WAS NOT INTENDED FOR VASCULAR USE, THE USER THEN PLACED TWO COOK-Z GIANTURCO-ROSCH TRACHEOBRONCHIAL STENTS IN THE MID-TO-DISTAL IVC VIA RIGHT FEMORAL ACCESS. OTHER MANUFACTURERS¿ 18-MILLIMETER AND 22-MILLIMETER BALLOONS WERE USED TO POST-DILATE THE STENTS. TWO COOK ZILVER STENTS WERE THEN SIMULTANEOUSLY PLACED IN THE RIGHT AND LEFT ILIAC VEINS, KISSING THE INFERIOR Z-STENT THAT WAS DEPLOYED IN THE IVC. ANOTHER MANUFACTURER¿S BALLOONS WERE THEN SIMULTANEOUSLY INFLATED WITHIN THE ZILVE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14052407 ↗
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- WALLSTENT® Endoprosthesis H965404130Boston Scientific Corporation · Prosthesis, tracheal, expandable11 reports
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- iCAST 85414Atrium Medical Corporation · Prosthesis, tracheal, expandable10 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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