Zilver 635 G36240Recalls & reported problems
Cook Ireland Ltd · Zilver 635 Biliary Stent · Class 2 · Implant
All models of Zilver 635 (55)
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 10827002362403), received between Jul 1, 2019 and Jul 1, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2019Fracture; Fracture
05-625; PATIENT 1341060; COOK ZILVER STENT FRACTURE. ON (B)(6) 2018, THE PATIENT RECEIVED: BRANCH GRAFT: ZBIS-10-61-58, LOT # AC956214 (LEFT SIDE). MAIN BODY: TFFB-30-125-ZT, LOT # 8399036. ILIAC LEG (SAME SIDE): ZSLE-16-56-ZT, LOT # 8344241 (LEFT SIDE). ILIAC LEG (OPPOSITE SIDE): ZSLE-24-56-ZT, LOT # 8088993; ZSLE-16-39-ZT LOT # 7547293 (RIGHT SIDE). ATRIUM ICAST: CAT. # 85419, LOT #422173002. COOK ZILVER 12 X 60 IN LEFT EXTERNAL ILIAC. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE DEVICES. A MOLDING BALLOON WAS USED WITHOUT COMPLICATIONS. PROCEDURAL ANGIOGRAPHY REVEALED PATENT DEVICES WITH NO KINK OR ENDOLEAK. CORE LAB EVALUATION REVEALED PATENT DEVICES WITH NO KINK OR ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (1-DAY POST- PROCEDURE). FOLLOW-UP IMAGING PERFORMED ON (B)(6) 2018-, (B)(6) 2018, AND (B)(6) 2019 ALL REVEALED PATENT AND INTACT DEVICES WITH NO KINK OR ENDOLEAK AS ASSESSED BY BOTH SITE AND CORE LAB. ON (B)(6) 2018, NOTIFICATION FROM CORE LAB NOTED A STENT FRACTURE OF AN ADDITIONAL STENT PRESENT IN THE LEFT EXTERNAL ILIAC ARTERY ON THE (B)(6) 2019 EXAM. AFTER OBTAINING THE OPERATIVE NOTE FROM THE SITE ON (B)(6) 2019, IT WAS LEARNED THAT THIS STE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8748120 ↗
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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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