CEREPAK FREEFORM MCR091530Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704082972), received between Dec 28, 2023 and Jun 25, 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.

• MalfunctionJun 25, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION OF THE LEFT MIDDLE MENINGEAL ARTERY (MMA), A FREEFORM MINI 1.5MM X 3CMCOIL (MCR091530, 31434948) WAS USED THROUGH A PLATO 17 160CM MICROCATHETER (MC). THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) WAS USED FOR THE FIRST DETACHMENT ATTEMPT. AFTER THE FAILED DETACHMENT ATTEMPT WITH THE HANDLE, THE MANUAL BREAK WAS USED WHICH ALSO FAILED. THE COIL WAS REMOVED WITH SUCCESS. NO PATIENT HARM OR DELAY OF CARE CAME FROM THIS DETACHMENT FAILURE. THE LEFT MMA WAS SUCCESSFULLY EMBOLIZED. MILD TO MODERATE TORTUOSITY WAS NOTED IN LEFT EXTERNAL CAROTID ARTERY (LECA) AND LEFT MIDDLE MENINGEAL ARTERY (MMA). ADDITIONAL EVENT INFORMATION RECEIVED ON 23-JUN-2025 INDICATED THAT SEVEN COILS WERE PLACED PREVIOUSLY DURING THE PROCEDURE. THERE WAS NO RESISTANCE DURING THE ADVANCEMENT OF THE COILS THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333351 ↗
• MalfunctionFeb 10, 2025Separation Failure; Material Twisted/Bent; Difficult or Delayed Separation; Separation Failure; Material Twisted/Bent; Difficult or Delayed Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TWO (2) COILS, A 4MM X 7CM CEREPAK FREEFORM (SCR120407 / 31149189) AND A 1.5MM X 3CM CEREPAK FREEFORM MINI (MCR091530 / 31136144) FAILED TO DETACH. ONE COIL DELIVERY WIRE WAS BADLY BENT UPON REMOVAL. ONLY ONE COIL WAS USED WITH THE DETACHMENT HANDLE (MDH1 / 102109430). NO ALTERNATIVE WAS ATTEMPTED (I.E., MANUAL DETACHMENT). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 10-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE COIL DELIVERY WIRE OF THE 4MM X 7CM CEREPAK FREEFORM (SCR120407) WAS BADLY BENT ON EXPLANT. THE DETACHMENT HANDLE (MDH1) WAS USED WITH BOTH COILS; ON THE 4MM X 7CM CEREPAK FREEFORM (SCR120407), THE DETACHMENT HANDLE WAS USED AS WELL AS THE MANUAL BREAK. ON THE 1.5MM X 3CM CEREPAK FREEFORM MINI (MCR091530), THE DETACHMENT HANDLE WAS USED ONCE AND THEN THE COIL WAS EXPLANTED; MANUAL DETACHMENT ATTEMPT WAS NOT MADE WITH THE 1.5MM X 3CM CEREPAK FREEFORM MINI (MCR091530). THE INFORMATION INDICATED THAT THE LOT NUMBER OF THE DETACHMENT HANDLE WAS 102109430. THE DETACHMENT HANDLE IS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21350286 ↗
• MalfunctionNov 18, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A VERY TORTOUS ANTERIOR CEREBRAL ARTERY (ACA), THE DOCTOR WAS UNABLE TO DETACH 3 COILS: FREEFORM MINI 1.5MM X 3CM (MCR091530, 31218790), FREEFORM MINI 1.5MM X 3CM (MCR091530, 31136144) AND A HELIFORM XSFT XL 2MM X 4 CM (XHE120204, 31317932). EACH COIL WAS ATTEMPTED INITIALLY WITH THE 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 20706866 ↗
• MalfunctionNov 18, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A VERY TORTOUS ANTERIOR CEREBRAL ARTERY (ACA), THE DOCTOR WAS UNABLE TO DETACH 3 COILS: FREEFORM MINI 1.5MM X 3CM (MCR091530, 31218790), FREEFORM MINI 1.5MM X 3CM (MCR091530, 31136144) AND A HELIFORM XSFT XL 2MM X 4 CM (XHE120204, 31317932). EACH COIL WAS ATTEMPTED INITIALLY WITH THE 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 20706719 ↗
• MalfunctionJan 19, 2024Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING ¿A VERY COMPLICATED¿ RECANALIZED LARGE LEFT POSTERIOR CEREBRAL ARTERY (PCA) ANEURYSM WITH MILD VESSEL TORTUOSITY, A 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31162599) WAS ADVANCED THROUGH A HEADWAY® DUO 156 MICROCATHETER (MICROVENTION) WITHOUT RESISTANCE. THE PHYSICIAN ATTEMPTED TO USE THE MANUAL DETACHMENT APPROACH. IT WAS REPORTED THAT BREAKING THE COIL AT THE SCORING MARK WAS DIFFICULT AND THE PULL WIRE BROKE; FORCEPS WERE USED IN AN UNSUCCESSFUL ATTEMPT TO PULL THE PULL WIRE BACK. THE COIL DID NOT DETACH AND THE SYSTEM WAS TAKEN OUT WITH THE COIL INTACT. A 1.5MM X 3CM CEREPAK FREEFORM MINI (MCR091530 / 31136144) WAS ADVANCED THROUGH THE SAME MICROCATHETER WITH MINIMAL FRICTION AROUND THE MANUAL BREAK MARKS. THE MANUAL BREAK WAS ATTEMPTED. THE COIL DETACHED INSIDE THE MICROCATHETER AND THE COIL WAS PUSHED FORWARD INTO THE ANEURYSM USING THE DELIVERY SYSTEM. THE COIL WAS LEFT IN THE ANEURYSM AND TREATED AS AN IMPLANT. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. PER THE COMPLAINT INFORMATION, ONLY THE 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208) IS AVAILABLE FOR RETURN; TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548134 ↗
• MalfunctionDec 28, 2023Fracture; Separation Failure; Fracture; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS COILING A POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM USING CEREPAK COILS. HE DEPLOYED FOUR (4) COILS WITHOUT INCIDENT. THE FIFTH COIL, A 1.5MM X 3CM CEREPAK FREEFORM MINI (MCR091530 / 31045746) WAS INSERTED INTO THE ANEURYSM WITHOUT DIFFICULTY. MANUAL BREAK TECHNIQUE WAS ATTEMPTED BUT WAS UNSUCCESSFUL DUE TO THE FRACTURING OF THE PULL WIRE. THE COIL WAS REMOVED WITHOUT ISSUE AND WAS OBSERVED INTACT IN THE FIELD. THE PHYSICIAN ADDED THREE (3) MORE CEREPAK COILS TO THE ANEURYSM WITHOUT DETACHMENT FAILURE. THERE WAS NO NEGATIVE PATIENT OUTCOME. ON 14-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT IS A (B)(6) FEMALE WITH A 5MM X 4MM UNRUPTURED PCOM ANEURYSM. THE INFORMATION INDICATED THAT THE MANUAL BREAK TECHNIQUE WAS USED ON ALL CEREPAK COILS. THE CONCOMITANT MICROCATHETER WAS A 0.0165-INCH INNER DIAMETER SL-10® MICROCATHETER (STRYKER). THERE WAS APPROXIMATELY FIVE (5) MINUTES ADDED TO THE PROCEDURE TIME IN TRYING TO GET THE COIL TO DETACH AND TRYING TO REMOVE IT CAREFULLY WITHOUT CAUSING OTHER COILS TO PROLAPSE OUT OF THE ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414113 ↗