Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0434-2026 — CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX10051

U.S. FDA — Device Enforcement · United States · 2025-10-02 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0434-2026
Date of alert
2025-10-02
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Cerenovus Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10886704083986
Reported risk: Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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