CEREPAK FREEFORM MCR091030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704082934), received between Jun 28, 2023 and Aug 6, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 2, 2025Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN WAS PERFORMING A PROCEDURE TO EMBOLIZE THE MIDDLE MENINGEAL ARTERY (MMA). THE DOCTOR WAS UTILIZING CEREPAK COILS FOR THE EMBOLIZATION. UPON DEPLOYING A FREEFORM MINI 1MM X 3CM COIL (MCR091030, 31140702) INTO THE ARTERY, THE FIRST ATTEMPT TO DETACH THE COIL WAS WITH A MECHANICAL DETACHMENT HANDLE (MDH1,102109430) WHICH WAS UNSUCCESSFUL. AT WHICH POINT THE DOCTOR WAS INSTRUCTED TO PERFORM A MANUAL BREAK TECHNIQUE WHICH WAS ALSO UNSUCCESSFUL. THE DOCTOR REMOVED THE COIL FROM THE MICROCATHETER SUCCESSFULLY AND THE COIL WAS SAVED FOR ANALYSIS. AFTER DEPLOYING 3 OTHER COILS SUCCESSFULLY, ANOTHER FREEFORM MINI 1MM X 3CM COIL (MCR091030, 31140702) WAS DEPLOYED AND UPON MECHANICAL HANDLE DETACHMENT BEING UNSUCCESSFUL, AGAIN, THE MANUAL BREAK TECHNIQUE WAS PERFORMED AT WHICH THE PULL WIRE FRACTURED AND COULD NOT BE RETRIEVED THEREFORE RESULTING IN A FAILED DETACHMENT. THE COIL WAS SUCCESSFULLY RETRIEVED THROUGH THE MICROCATHETER, BUT THE DEVICE WAS DESTROYED AND UNABLE TO BE SAVED FOR ANALYSIS. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-JUL-2025 CONFIRMED THAT TWO FREEFORM MINI 1MM X 3CM COILS FAILED TO DETACH. A TERUMO HEADWAY DUO 156

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727225 ↗
• MalfunctionAug 6, 2025Fracture; Separation Failure; Fracture; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN WAS PERFORMING A PROCEDURE TO EMBOLIZE THE MIDDLE MENINGIAL ARTERY (MMA). THE DOCTOR WAS UTILIZING CEREPAK COILS FOR THE EMBOLIZATION. UPON DEPLOYING A FREEFORM MINI 1MM X 3CM COIL (MCR091030, 31140702) INTO THE ARTERY, THE FIRST ATTEMPT TO DETACH THE COIL WAS WITH A MECHANICAL DETACHMENT HANDLE (MDH1,102109430) WHICH WAS UNSUCCESSFUL. AT WHICH POINT THE DOCTOR WAS INSTRUCTED TO PERFORM A MANUAL BREAK TECHNIQUE WHICH WAS ALSO UNSUCCESSFUL. THE DOCTOR REMOVED THE COIL FROM THE MICROCATHETER SUCCESSFULLY AND THE COIL WAS SAVED FOR ANALYSIS. AFTER DEPLOYING 3 OTHER COILS SUCCESSFULLY, ANOTHER FREEFORM MINI 1MM X 3CM COIL (MCR091030, 31140702) WAS DEPLOYED AND UPON MECHANICAL HANDLE DETACHMENT BEING UNSUCCESSFUL, AGAIN, THE MANUAL BREAK TECHNIQUE WAS PERFORMED AT WHICH THE PULL WIRE FRACTURED AND COULD NOT BE RETRIEVED THEREFORE RESULTING IN A FAILED DETACHMENT. THE COIL WAS SUCCESSFULLY RETRIEVED THROUGH THE MICROCATHETER, BUT THE DEVICE WAS DESTROYED AND UNABLE TO BE SAVED FOR ANALYSIS. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-JUL-2025 CONFIRMED THAT TWO FREEFORM MINI 1MM X 3CM COILS FAILED TO DETACH. A TERUMO HEADWAY DUO 156

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727028 ↗
• MalfunctionJul 1, 2025Premature Separation; Premature Separation

  A HEALTHCARE PROFESSIONAL REPORTED THAT WHILE DEPLOYING A FREEFORM MINI 1MM X 3CM COIL (MCR091030, 31177297) IN THE ANEURYSM, THE COIL DETACHED PREMATURELY. THE USER WAS ABLE TO USE PUSHER WIRE TO PUSH THE REST OF THE COIL INTO THE ANEURYSM WITHOUT AN EVENT. THE DELIVERY SYSTEM FOR THE COIL IS AVAILABLE FOR RETURN, HOWEVER THE COIL ITSELF IS NOT, SINCE IT WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375680 ↗
• MalfunctionJul 8, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION TO A POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM. THE FIRST 4 COILS WERE DEPLOYED WITHOUT AN ISSUE. THE 5TH COIL, A FREEFORM MINI 1MM X 3CM ( MCR091030, 31140702) WAS SITUATED AND DETACHMENT WAS ATTEMPTED WITH A MECHANICAL DETACHMENT HANDLER (MDH1, 102109430) WHICH DID NOT DETACH. MANUAL BREAK METHOD WAS THEN ATTEMPTED, ONCE AGAIN FAILING TO DETACH AT BOTH 2CM PULL AND 4CM PULL. COIL WAS REMOVED AND A 6TH COIL, A FREEFORM MINI 1MM X 2CM (MCR091020, 31131257) WAS POSITIONED. AFTER ATTEMPTING AND FAILING DETACHMENT WITH HANDLE MANUAL BREAK METHOD WAS UTILIZED AGAIN. THE COIL STILL FAILED TO DETACH AND WAS THEREFORE REMOVED. CASE WAS COMPLETED WITH ONE COMPETITIVE COIL. THERE WAS A 10-MINUTE PROCEDURAL DELAYS DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 24-JUN-2024 INDICATING THAT A PHENOM 17 150CM MICROCATHETER WAS USED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICES THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS MODERATELY TORTUOUS, NOTHING ¿EXTREME¿ PER T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689482 ↗
• 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 19272090 ↗
• MalfunctionJun 28, 2023Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM TO THE MIDDLE MENINGEAL ARTERY, A FREEFORM MINI 1MM X 1.5CM COIL (MCR091030, 31045735) FAILED TO DETACH. NO PREVIOUS COILS HAD BEEN PREVIOUSLY IMPLANTED. THERE HAD NOT BEEN ANY RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE SL10 STRYKER MICROCATHETER (MC) OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE HAD BEEN THREE ATTEMPTS MADE USING THE DETACHMENT HANDLE PRIOR TO MANUAL DETACHMENT. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THERE WAS NO VESSEL ACUTE BENDS. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS ABOUT A 20-MINUTE PROCEDURAL DELAY, WE HAD TO BRING IN THE BALT COIL CART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215908 ↗