CEREPAK FREEFORM MCR091525Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704082965), received between May 8, 2024 and Nov 3, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON 03-SEP-2025, AS EACH COIL LISTED: A 1MM X 2CM CEREPAK FREEFORM MINI (MCR091020 / 31345668), A 1.5MM X 2.5CM CEREPAK FREEFORM MINI (MCR091525 / 31216617), 1MM X 2CM CEREPAK FREEFORM MINI (MCR091020 / 31258390), AND 1MM X 3CM CEREPAK FREEFORM MINI (MCR091030 / 31585342) WAS BEING ADVANCED INTO THE CONCOMITANT ECHELON¿ 10 MICROCATHETER (MEDTRONIC), THE PHYSICIAN ENCOUNTERED RESISTANCE AS THE COIL ENTERED THE MICROCATHETER. THE PHYSICIAN RE-SHEATHED THE COIL, CHECKED TO ENSURE THE INTRODUCER WAS ¿HUBBED¿ CORRECTLY WITHIN THE MICROCATHETER, CONFIRMED THE SYSTEM WAS BEING FLUSHED AND TRIED ADVANCE THE COIL AGAIN. IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE MORE THAN APPROXIMATELY 5 CM INTO THE MICROCATHETER. EACH COIL WAS PLACED ON THE BACK TABLE FOR INVESTIGATION FOLLOWING THE CASE. THE TWO COILS THAT WERE AVAILABLE FOR RETURN: 1MM X 2CM CEREPAK FREEFORM MINI (MCR091020) AND 1.5MM X 2.5CM CEREPAK FREEFORM MINI (MCR091525) WOULD NOT ADVANCE OUTSIDE OF THE INTRODUCER. NONE OF THE COILS WERE INTRODUCED INTO THE PATIENT¿S BODY. THE INABILITY OF THE COILS TO BE ADVANCED THROUGH THE MICROCATHETER DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444656 ↗
• MalfunctionJun 18, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, EACH OF THE THREE COILS USED A 1.5MM X 4CM CEREPAK FREEFORM MINI (MCR091540 / 31207073), A 1MM X 4CM CEREPAK FREEFORM MINI (MCR091040 / 31045747), AND A 1.5MM X 2.5CM CEREPAK FREEFORM MINI (MCR091525 / 31149187) DID NOT DETACH USING BOTH MANUAL BREAK AND WITH THE DETACHMENT HANDLE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 14-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY. THE CATALOG AND LOT NUMBER OF THE DETACHMENT HANDLE USED WAS MDH1 / 102109430. THE SAME DETACHMENT HANDLE WAS USED WITH ALL THREE COILS; IT WAS INDICATED AS NOT AVAILABLE FOR RETURN. MANUAL BREAK WAS ATTEMPTED ON THE FIRST COIL IMPLANTED. THE INFORMATION INDICATED THAT ¿THIS IS WHEN THE SYSTEM APPEARED TO BE BROKEN INTO TWO PIECES. THE PULL WIRE WAS NOT ATTACHED. MECHANICAL [DETACHMENT] WAS ATTEMPTED ON THE THIRD COIL (SECOND ATTEMPT WAS SUCCESSFUL) FIRST, THIS WAS UNSUCCESSFUL, WE MOVED TO MANUAL BREAK IMMEDIATELY WITHOUT SUCCESS. WE WRAPPED THE PULL WIRE AROUND FINGER AND PULLED AND THE PULL WIRE APPEARED TO HAVE BROKEN. THE FOUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563948 ↗
• MalfunctionMay 8, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING COIL EMBOLIZATION OF A MIDDLE MENINGEAL ARTERY (MMA), TWO COILS, A 1MM X 3CM CEREPAK FREEFORM MINI (MCR091030 / 31177297) AND A 1.5MM X 2.5CM CEREPAK FREEFORM MINI (MCR091525 / 31149187) DID NOT DETACH CORRECTLY. THE CEREPAK TM DETACHMENT HANDLE (MDH1 / 102109430) AS WELL AS THE MANUAL BREAK WERE ATTEMPTS AND NEITHER METHOD WORKED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272109 ↗