Zilver Flex 35 G50164Recalls & reported problems
Cook Incorporated · Zilver Flex 35 Biliary Self-Expanding Stent · Class 2 · Implant
Data updated Oct 16, 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 10827002501642), received between Feb 15, 2018 and Feb 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
- Scratched Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2018Material Integrity Problem; Scratched Material
IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS ATTEMPTING TO PLACE THE STENT HE ENCOUNTERED TRACKING DIFFICULTY BETWEEN TWO PREVIOUSLY PLACED STENTS. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. TWO G50164 STENTS HAD ALREADY BEEN PLACED IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY- ONE IN THE PROXIMAL PORTION AND ONE IN THE MOST DISTAL PORTION. A THIRD DEVICE WAS TO BE PLACED IN THE MIDDLE SECTION OF THE SUPERFICIAL FEMORAL ARTERY CONNECTING THE OTHER TWO STENTS, BUT THE STENT WOULD NOT TRACK THROUGH THE OTHER STENTS. IT WAS ASSUMED IT WAS DUE TO THE TRANSITION BETWEEN THE STENT CATHETER AND THE 0.018 BOSTON SCIENTIFIC V-18 HYDROPHILIC WIRE THAT WAS IN USE AT THAT TIME. THE PHYSICIAN THEN TREATED THE PATIENT BELOW THE KNEE WITH A BALLOON AND LASER, THEN CHANGED TO A NEW WIRE AND ATTEMPTED TO PLACE THE STENT ONCE MORE, BUT IT WAS DIFFICULT TO PASS THROUGH THE FIRST STENT AND WOULD NOT OVERLAP WITH THE SECOND STENT. THE PHYSICIAN THEN ATTEMPTED TO EXPAND THE STENTS WITH A BALLOON, BUT THIS WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED AND EXAMINED, REVEALING THAT THE TIP OF THE STENT PLACEMENT CATHETER WAS JAGGED. A NEW DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED W
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7273932 ↗
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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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