CEREPAK UNIFORM FCX100412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704084006), received between Apr 1, 2024 and Dec 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 2, 2025Class IOpen, Classified

   Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.

   Z-0434-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, IN A VERY LARGE BASILIAR ANEURYSM, THE PHYSICIAN WAS UNABLE TO DETACH A HELIFORM XL 4MM X 15 CM COIL (SHD180415, 31098462) AND A UNIFORM 4MM X 11.5 CM COIL (FCX100412, 31207070). EACH COIL WAS ATTEMPTED INITIALLY WITH A MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN). AFTER THAT WAS UNSUCCESSFUL, THE MANUAL BREAK WAS ATTEMPTED WITHOUT SUCCESS. EACH COIL WAS TAKEN OUT OF THE ANEURYSM WITHOUT ISSUES AND ANOTHER COIL WAS USED WITH THE SAME MICROCATHETER (PLATO 17 STRAIGHT). WITH EACH COIL, THE MICROCATHETER OUTSIDE THE BODY WAS STRAIGHT. NO NEGATIVE IMPACT ON PATIENT AND NO SIGNIFICANT DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895296 ↗
• MalfunctionApr 1, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE OF AN INTRACRANIAL ANEURYSM IN A 61-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION, THE 4MM X 11.5CM CEREPAK UNIFORM (FCX100412 / 31126840) FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS NOT DELAYED; IT WAS REPORTED TO HAVE SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. ON 20-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL ACCOUNT SPECIALIST. PER THE INFORMATION, THE PROCEDURE WAS TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. THE DETACHMENT ATTEMPTS WERE THREE MANUAL BREAKS AND ON THE THIRD ATTEMPT, THE FILAMENT DETACHMENT WIRE BROKE. THE COIL WAS NOT STRETCHED AND IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE MICROCATHETER USED WAS AN EXCELSIOR SL-10 45°(STRYKER). THE PROCEDURE WAS COMPLETED WITH A SHORTER CEREPAK UNIFORM COIL, A 4MM X 7.5CM CEREPAK UNIFORM (FCX100407).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016317 ↗