CEREPAK UNIFORM FCX181447Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704084402), received between Mar 13, 2025 and Mar 13, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A LARGE CAVERNOUS ANEURYSM 21X18, FLOW DIVERTER WAS PLACED IN RIGHT INTERNAL CAROTID ARTERY (RICA). THE SL-10 MICROCATHETER WAS JAILED IN ANEURYSM. A UNIFORM XL 20MM X 50 CM COIL (FCX182050, 3126862) DEPLOYED AND ATTEMPT TO DETACH WITH MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) BUT FAILED TWICE. ATTEMPTED MANUAL BREAK, HOWEVER, IT ALSO FAILED. THE COIL WAS PULLED OUT WITH NO PROBLEM AND A NEW 18MM X 46CM CEREPAK UNIFORM DETACHED WITH MECHANICAL HANDLE. NEXT, A COIL 16MM X47CM WAS ALSO PLACED AND DETACHED WITH HANDLE. THEN, A UNIFORM XL 14MM X 47 CM COIL (FCX181447, 31177725) WAS PLACED AND DETACHMENT FAILED WITH TWO ATTEMPTS. MANUAL BREAK WAS ATTEMPTED BUT ALSO FAILED AND COIL HAD TO REMOVE WITHOUT INCIDENT. THE DOCTOR USED A NON J&J COIL AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS FINE IN POST-OP. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-MAR-2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE TO THE EMBOLIC COILS OR ANY DEVICE COMPONENT. THERE WAS SOME VESSEL TORTUOSITY BUT NOT SEVERE. THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596416 ↗