CEREPAK FREEFORM MCR092060Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704083016), received between Dec 5, 2023 and Sep 4, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31530985) DID NOT DEPLOY IN DEFECT. THE ISSUE DELAYED THE PROCEDURE BY 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965369 ↗
• MalfunctionMay 2, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CAROTID ARTERY PROCEDURE, THE FOLLOWING COILS WERE ADVANCED THROUGH THE EXCELSIOR SL-10® MICROCATHETER (STRYKER) INTO THE FACIAL ARTERY WITHOUT ISSUES: 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31107820), 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31112708), 4MM X 10CM CEREPAK FREEFORM (SCR120410 / 31177726), 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31459691), 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167), 2MM X 6CM CEREPAK HELIFORM XTRASOFT XL (XHE120206 / 31216620), AND 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31361855). FLUSH LINE WAS RUNNING. THE DISTAL ANATOMY WAS EXTREMELY TORTUOUS. THE PROXIMAL PORTION OF THE SYSTEM WAS STRAIGHT, AND MANUAL DETACHMENT WAS ATTEMPTED FIRST WITH THE DETACHMENT HANDLE (MDH1 / 102109430) AND THEN WAS SHIFTED TO MANUAL BREAK WITHOUT ANY SUCCESSFUL DETACHMENT. IT WAS REPORTED THAT OTHER CEREPAK COILS AND STRYKER COILS WERE BOTH PLACED BEFORE AND AFTER THESE COILS WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 30-APR-2025, RESPONSES TO ADDITIONAL INFORMATION REQUESTS WERE RECEIVED. PER THE ADDITIONAL INFORMATION, TWO DETACHMENT HANDLES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953756 ↗
• MalfunctionMay 2, 2025Separation Failure; Difficult to Advance; Premature Separation; Separation Failure; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR MENINGEAL ARTERY (MMA) EMBOLIZATION USING CEREPAK COILS, DURING THE DETACHMENT OF THE FIRST COIL, THE HANDLE (MDH1 / 102109430) GOT STUCK ON THE PROXIMAL PULL WIRE. ONCE THE COIL WAS DETACHED USING THE MANUAL BREAK METHOD AND THE DELIVERY SYSTEM WAS REMOVED FROM THE MICROCATHETER, THE HANDLE WAS REMOVED WITH A LITTLE FORCE. TO ENSURE THIS DID NOT HAPPEN ON THE FOLLOWING COILS, A NEW DETACHMENT HANDLE WAS USED. IN THE SAME PROCEDURE, A 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31521944) FAILED TO DETACH. DURING THE ADVANCEMENT OF THE COIL, ¿THE ENGINEER FRACTURE POINT OF THE COIL BROKE PREMATURELY.¿ THE PHYSICIAN CONTINUED TO ADVANCE THE COIL, BUT RESISTANCE WAS MET. THE ENTIRE MICROCATHETER AND COIL HAD TO BE REMOVED. AFTER FURTHER INSPECTION, THE CONCOMITANT PLATO® MICROCATHETER (SCIENTIA VASCULAR) WAS OBSERVED TO HAVE A SMALL KINK, WHICH PREVENTED THE COIL FROM ADVANCING OR BEING REMOVED. A NEW MICROCATHETER, AN SL-10® MICROCATHETER (STRYKER), AND COIL WERE USED WITH SUCCESS. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 30-APR-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953215 ↗
• MalfunctionApr 28, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO THE MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN USED A CEREPAK FREEFORM MINI (MCR091540) WITH NO ISSUE WITH DETACHMENT. THEN A SECOND FREEFORM MINI 2MM X 6CM COIL (MCR092060, 31111682) WAS USED. THE OPERATING ROOM (OR) TECHNICIAN USED THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) AND THE COIL DIDN'T DETACH. A 3RD FREEFORM MINI 2MM X 6CM COIL (MCR092060, 31111682) WAS USED, AND THIS TIME THE PHYSICIAN FIRST USED A MECHANICAL DETACHER, IT FAILED. THEN TRIED A MANUAL METHOD AND IT AGAIN FAILED TO DETACH THE COIL. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-APR-2025 INDICATED THAT A HEADWAY DUO 156CM MICROCATHETER WAS USED. NEITHER THE TECH NOR PHYSICIAN EXPRESSED ANY PARTICULAR OR DIFFICULTY IN ADVANCEMENT OR POSITIONING THE COILS. THE PACKAGING OF THE COILS WAS INTACT AND IN PROPER SEALING. THE COILS ITSELF WERE HANDED OVER TO THE TECH AND AS FAR AS WE COULD SEE THERE WAS NO ISSUE IN THAT REGARD. THE VESSEL WAS EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE PHYSICIAN DOES NOT KNOW EXACTLY WHY THE EVENT HAPPENED, ¿MAYBE IT WAS HIS FIRST TIME USING OUR COILS ON PATIENTS¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918126 ↗
• MalfunctionApr 28, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO THE MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN USED A CEREPAK FREEFORM MINI (MCR091540) WITH NO ISSUE WITH DETACHMENT. THEN A SECOND FREEFORM MINI 2MM X 6CM COIL (MCR092060, 31111682) WAS USED. THE OPERATING ROOM (OR) TECHNICIAN USED THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) AND THE COIL DIDN'T DETACH. A 3RD FREEFORM MINI 2MM X 6CM COIL (MCR092060, 31111682) WAS USED, AND THIS TIME THE PHYSICIAN FIRST USED A MECHANICAL DETACHER, IT FAILED. THEN TRIED A MANUAL METHOD AND IT AGAIN FAILED TO DETACH THE COIL. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-APR-2025 INDICATED THAT A HEADWAY DUO 156CM MICROCATHETER WAS USED. NEITHER THE TECH NOR PHYSICIAN EXPRESSED ANY PARTICULAR OR DIFFICULTY IN ADVANCEMENT OR POSITIONING THE COILS. THE PACKAGING OF THE COILS WAS INTACT AND IN PROPER SEALING. THE COILS ITSELF WERE HANDED OVER TO THE TECH AND AS FAR AS WE COULD SEE THERE WAS NO ISSUE IN THAT REGARD. THE VESSEL WAS EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE PHYSICIAN DOES NOT KNOW EXACTLY WHY THE EVENT HAPPENED, ¿MAYBE IT WAS HIS FIRST TIME USING OUR COILS ON PATIENTS¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918101 ↗
• MalfunctionJan 10, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31393524) AND THE 2MM X 4CM CEREPAK FREEFORM MINI (MCR092040 / 31140703) DID NOT DEPLOY WHEN PLACED PROPERLY AND MANUAL BREAK WAS ATTEMPTED. BOTH COILS WERE SUBSEQUENTLY REMOVED SAFELY AND WERE DISPOSED OF. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21132227 ↗
• MalfunctionAug 5, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE BOTH COILS, A 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31112710) AND A 1MM X 4CM CEREPAK FREEFORM MINI (MCR091040 / 31162592) AND MANUAL DETACHMENT WAS ATTEMPTED WITH NO SUCCESS. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 24-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE INTENDED PROCEDURE WAS TARGETING THE LEFT MIDDLE MENINGEAL ARTERY (MMA). DETACHMENT HANDLE WAS NOT USED, MANUAL BREAK WAS USED FOR BOTH COILS. THE MICROCATHETER USED WITH THE COIL WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). THE INFORMATION ALSO INDICATED THAT THE PHYSICIAN DESCRIBED THAT ¿HE MAY HAVE HAD AN UNNECESSARY BEND IN THE MICROCATHETER THAT COULD HAVE LED TO THE NON-DETACHMENT.¿ WHEN THE COILS WERE REMOVED, THEY WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS. THE COILS WERE NOT STRETCHED. THE PROCEDURE WAS COMPLETED USING BALT COILS. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911188 ↗
• MalfunctionJun 18, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRE-SURGICAL EMBOLIZATION OF AN ARTERIOVENOUS MALFORMATION (AVM) AT THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, THE PHYSICIAN PLACED A 2MM X 6CM CEREPAK FREEFORM MINI COIL (MCR092060 / 31162594) INTO THE ANEURYSM. THE COIL DEPLOYED WITHOUT ISSUE. THE PHYSICIAN THEN INSERTED THE CEREPAK TM DETACHMENT HANDLE (MDH1 / 102109430) OVER THE PROXIMAL DETACHMENT ZONE, THEN WENT TO PULL THE TRIGGER TO DETACH; THE COIL DID NOT DETACH. THE PHYSICIAN THEN MOVED TO MANUAL DETACHMENT. IT WAS REPORTED THAT THE PHYSICIAN ¿BROKE¿ AT THE CORRECT PLACE AND THE PROXIMAL DETACHMENT WIRE BROKE FREE, BUT THE COIL DID NOT DETACH. A DECISION WAS THEN MADE AT THAT TIME TO RETRIEVE AND PULL THE COMPLETE SYSTEM OUT OF THE PATIENT AND START OVER WITH NEW COIL. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. THE COIL WAS RETRIEVED, REMOVED, AND REPLACED WITHOUT ISSUE. ON 13-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE LOCATION OF THE AVM WAS THE M2 SEGMENT. PER THE INFORMATION, THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE MICROCATHETER USED WAS A PLATO® 17 MICROCATHETER (S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564051 ↗
• MalfunctionApr 29, 2024Product Quality Problem; Product Quality Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, WHILE PLACING A FREEFORM MIN COIL INSIDE THE ANEURYSM, NO DETACHMENT MARKER WAS FOUND AT ALL UNDER FLUORO. THEREFORE, THE PHYSICIAN DIDN¿T KNOW WHEN TO DETACH THE COIL. THE COIL WAS REMOVED, AND CASE CARRIED ON. TWO COILS, A FREEFORM MINI 2MM X 6CM ( MCR092060, 31162594) AND A FREEFORM MINI 2MM X 4CM (MCR092040, 31162593) ARE BEING INCLUDED IN THE COMPLAINT SINCE IT IS NOT CLEAR WHICH ONE HAD THE ISSUE. ADDITIONAL EVENT INFORMATION RECEIVED ON 29-APR-2024 INDICATED THAT THERE WAS NO PATIENT INJURY. THE CASE WAS FINISHED WITH ANOTHER COIL. THERE WAS A 3-MINUTE PROCEDURE DELAY DUE TO THE EVENT, THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203231 ↗
• MalfunctionApr 1, 2024Fracture; Separation Failure; Fracture; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A FREEFORM MINI 2MM X 6CM COIL (MCR092060, 31162594) WAS PLACED INTO A LEFT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM. THIS WAS THE FIFTH COIL TO BE PLACED. THE PHYSICIAN ATTEMPTED TO DETACH USING MANUAL BREAK. COIL DID NOT DETACH ¿ VERIFIED UNDER FLUORO. PROXIMAL END OF PUSHER TUBE DETACHED FROM PULL WIRE AND SLID OFF. THE PHYSICIAN ATTEMPTED TO WRAP PULL WIRE AROUND HIS FINGER AND PULL. COIL STILL WOULD NOT DETACH ¿ VERIFIED UNDER FLUORO. PULL WIRE BROKE AFTER PULLING SEVERAL TIMES WITHOUT SUCCESSFUL DETACHMENT. THE PHYSICIAN ATTEMPTED TO PULL REMAINING PORTION OF PULL WIRE USING HEMOSTAT. COIL STILL WOULD NOT DETACH AS VERIFIED UNDER FLUORO. COIL WAS REMOVED FROM ANEURYSM AND MICROCATHETER WITHOUT DISTURBANCE TO COIL MASS. NO INJURY TO PATIENT. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 21-MAR-2024 INDICATING THAT A STRYKER SL-10 MICROCATHETER (MC) WAS USED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WERE NO ATTEMPTS USING THE DETACHMENT HANDLE. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS MODE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012333 ↗
• MalfunctionFeb 12, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING THE LEFT MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN ATTEMPTED TO PLACE FIVE (5) COILS VIA A STRAIGHT SL-10® MICROCATHETER (STRYKER) WITH THE CEREPAK TM MECHANICAL DETACHMENT HANDLE (MDH1 / 101456956) WITH THE LAST OF THE FIVE COILS VIA MANUAL BREAK. IT WAS REPORTED THAT ALL FIVE COILS FAILED TO DETACH. THE PHYSICIAN DECIDED TO USE ORBIT GALAXY COILS USING THE SAME STRAIGHT SL-10 MICROCATHETER WITH SUCCESS. THE FOLLOWING FOUR (4) COILS WERE USED WITH THE MECHANICAL DETACHMENT HANDLE: A 3.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR123505 / 31146338), A 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31077168), A 2.5MM X 3.5CM CEREPAK FREEFORM XTRASOFT (XCR122535 / 31140719), AND ANOTHER 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31077168). THE FIFTH COIL THAT FAILED TO DETACH VIA MANUAL BREAK WAS A 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31112710). NONE OF THE COILS WERE OBSERVED STRETCHED WHEN THEY WERE REMOVED. ALL FIVE COILS WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS WHEN THEY WERE REMOVED FROM THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691806 ↗
• MalfunctionDec 5, 2023Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE MANUAL BREAK WAS USED AS THE PRIMARY DETACHMENT APPROACH. SIX COILS WERE USED IN THIS THIS CASE. DISTAL INTERNAL CAROTID ARTERY (ICA) WITH MINIMAL TORTUOSITY. THE FOURTH COIL, A FREEFORM MINI 2MM X 6CM (MCR092060, 31112710). WAS ADVANCED THROUGH AN UNSPECIFIED THE MICROCATHETER (MC) WITHOUT ANY ISSUE. WHEN ATTEMPTING TO DETACH THE COIL, THE SUTURE BROKE WHEN TRYING TO PULL BACK THE PULL WIRE. THE COIL DID DETACH DURING THIS PROCESS. THE END OF THE DETACHMENT WAS REMOVED COMPLETELY. THE COIL REMAINED IN THE ANEURYSM. SAME MICROCATHETER WAS USED DURING ENTIRE CASE. ANOTHER COIL OF THE SAME SIZE AND LOT NUMBER WAS USED AS THE NEXT COIL WITHOUT ISSUES. NO NEGATIVE PATIENT IMPACT OR SIGNIFICANT PATIENT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266013 ↗