CEREPAK FREEFORM MCR092555Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704083047), received between Oct 25, 2023 and Oct 25, 2023 — 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 16, 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.

• MalfunctionOct 25, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE MIDDLE MENINGEAL ARTERY, A FREEFORM MINI COIL 2.5MM X 5.5CM (MCR092555, 31073453) FAILED TO DETACH. THE COIL WAS ADVANCED USING STEPS PER THE INSTRUCTIONS FOR USE (IFU) INTO DETACHMENT POSITION IN THE POSTERIOR BRANCH OF THE MIDDLE MENINGEAL ARTERY USING A SL-10 STRAIGHT MICROCATHETER (MC). THE CEREPAK DETACHMENT HANDLE WAS USED 3 TIMES TO DETACH, ALL OF WHICH WERE UNSUCCESSFUL WITH VERIFICATION BY PULLING BACK ON THE DELIVERY SYSTEM UNDER FLUORO. THE MANUAL BREAK METHOD WAS THEN ATTEMPTED AFTER RE-ADVANCING THE COIL INTO DETACHMENT POSITION PER THE IFU. THIS METHOD TOO WAS UNSUCCESSFUL WITH VERIFICATION BY PULLING BACK ON THE DELIVERY SYSTEM UNDER FLUORO. THE COIL WAS THEN RETRACTED FROM THE PARENT VESSEL INTO THE SL-10 AND THE ENTIRE SYSTEM (COIL, DELIVERY SYSTEM AND MICROCATHETER WITH RHV) WERE REMOVED FROM THE PATIENT, PLACED ON THE BACK TABLE FOR INSPECTION AND PLACED INTO A BIOHAZARD BAG FOR RETURN TO CERENOVUS FOR ANALYSIS. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003305 ↗