CEREPAK FREEFORM MCR091040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886704082941), received between Nov 8, 2023 and Aug 19, 2025 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO THE MENINGEAL ARTERY, A FREEFORM MINI 1MM X 4CM COIL (MCR091040, 31555207) FAILED TO DETACH USING THE MANUAL DETACHING TECHNIQUE. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-AUG-2025 INDICATED THAT A HEADWAY DUO 156CM MICROCATHETER WAS USED. TEN COILS WERE PREVIOUSLY IMPLANTED DURING THE PROCEDURE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. NO ATTEMPTS WERE MADE USING THE DETACHMENT HANDLE. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THERE WAS NO ANATOMICAL TORTUOSITY AT THE DISTAL, AORTIC ARCH OR AT THE ILIOFEMORAL REGIONS. THE DEVICE DEFICIENCY DID NOT RESULT IN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841872 ↗
• MalfunctionAug 8, 2025Stretched; Premature Separation; Stretched; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED ON 07-AUG-2025, DURING AN ENDOVASCULAR COIL EMBOLIZATION OF A LEFT PARIETAL BRANCH OF THE MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN INSERTED THE 1MM X 4CM CEREPAK FREEFORM MINI (MCR091040 / 31555207) AS COIL NUMBER 5 (MIX OF OPTIBLOCK COILS (BALT) AND FREEFORM MINIS PRECEDED) THROUGH A PLATO¿ MICROCATHETER (SCIENTIA VASCULAR). THE PHYSICIAN WENT TO DETACH THE COIL USING A MECHANICAL DETACHMENT HANDLE (MDH1 / LOT# UNKNOWN). AS THE PHYSICIAN PULLED THE COIL PUSHER WIRE BACK, THE COIL STARTED TO COME WITH THE PUSHER WIRE, AND IT DETACHED IN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO ADVANCE THE COIL BACK OUT INTO THE VESSEL. THE PHYSICIAN THEN INSERTED AN ARISTOTLE® 14 GUIDEWIRE (SCIENTIA VASCULAR) TO PUSH THE COIL INTO THE COIL BACK, AS HE WAS PULLING THE WIRE OUT, THE 1MM X 4CM CEREPAK FREEFORM MINI COIL STRETCHED ONTO THE WIRE. THE PHYSICIAN PULLED OUT THE PLATO MICROCATHETER, THE ARISTOTLE GUIDEWIRE, AND THE 1MM X 4CM CEREPAK FREEFORM MINI COIL AND REMOVED THEM ALL FROM THE PATIENT. THE PHYSICIAN WAS ABLE TO RE-ACCESS THE PARIETAL BRANCH USING A NEW PLATO MICROCATHETER AND CONTINUED WITH THE COIL EMBOLIZATION. THERE WAS NO PROCEDURE DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22757411 ↗
• MalfunctionJun 27, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 1MM X 4CM CEREPAK FREEFORM MINI (MCR091040 / 31434946) DID NOT DETACH. MANUAL DETACHMENT AND WITH THE DETACHMENT HANDLE (MDH1 / 102109430) WERE MADE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 5 MINUTES DUE TO COIL REMOVAL. THERE WAS NO OTHER MEDICAL INTERVENTION, NO NEGATIVE IMPACT ON THE PATIENT. ON 27-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION. THERE WAS NO EVIDENCE OF BLOOD FLOW INTERRUPTION AS A RESULT OF THE REPORTED ISSUE. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. IT WAS REPLACED WITH ANOTHER 1MM X 4CM CEREPAK FREEFORM MINI (MCR091040). THE PROCEDURE WAS DELAYED BY APPROXIMATELY 3 TO 5 MINUTES. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE CONCOMITANT MICROCATHETER USED WAS THE HEADWAY® DUO 156 MICROCATHETER (TERUMO NEURO). THE LOT NUMBER OF THE DETACHMENT HANDLE WAS 102109430.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347330 ↗
• MalfunctionMay 16, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS USING A PROWLER SELECT LPES MICROCATHETER IN A SMALL BRANCH OFF THE LEFT SUBCLAVIAN ARTERY THAT NEEDED COIL EMBOLIZATION. SEVERAL COILS WERE USED AND THEN WHEN THE 1MM X 4CM CEREPAK FREEFORM MINI COIL (MCR091040 / 31162592) WAS SELECTED FOR USE, IT WAS UNABLE TO BE USED AS THE COIL WOULD NOT EXIT THE INTRODUCER SHEATH. THE PHYSICIAN WAS NOT ABLE TO GET THE COIL TO DEPLOY OUT OF THE PINK INTRODUCER. THE COIL WAS SET ASIDE WITH A NOTE WHILE OTHER COILS WERE USED TO FINISH HE PROCEDURE. THE CONCOMITANT MICROCATHETER WAS DISCARDED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 20-MAR-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE FEMALE PATIENT HAD A SPONTANEOUS RUPTURE OF THIS VESSEL TO PECTORAL AND NEEDED EMBOLIZATION. THE ADDITIONAL INFORMATION INDICATED THAT A 2MM, 1.5MM, AND A 1MM COILS WERE USED. THE PATIENT¿S VESSEL WAS ¿VERY SMALL¿ WITH A TIGHT TURN AT OSTIUM WHICH MADE ACCESS TROUBLESOME, BUT ACCESS WAS MAINTAINED. THE 1MM X 4CM CEREPAK FREEFORM MINI COIL NEVER MADE IT INTO THE HUB OF THE MICROCATHETER AND IT WAS SET ASIDE, AND ANOTHER COIL W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22040350 ↗
• MalfunctionApr 28, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT TWO FREEFORM MINI 1MM X 4CM COILS (MCR091040/31434946) WOULD NOT ADVANCE. THE COILS WOULD NOT EXIT THE INTRODUCER SHEATH. PROPER FLUSHING WAS DONE WITH INTRODUCER SHEATH PRIOR TO ADVANCING COILS. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-MAR-2025 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE MICROCATHETER WAS NOT REMOVED OR REPLACED DURING PROCEDURE. THE TARGET VESSEL WAS THE MIDDLE MENINGEAL ARTERY. THE DEVICE DID NOT APPEAR DAMAGED AT THE TIME OF PROCEDURE. THE DEVICES WERE NOT DAMAGED AFTER PROCEDURE WAS COMPLETE. THE DELIVERY WIRE WAS KINKED WHILE WE WERE INSPECTING INTRODUCER SHEATH. THE COILS NEVER PASSED THROUGH THE INTRODUCER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917723 ↗
• MalfunctionApr 25, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT TWO FREEFORM MINI 1MM X 4CM COILS (MCR091040/31434946) WOULD NOT ADVANCE. THE COILS WOULD NOT EXIT THE INTRODUCER SHEATH. PROPER FLUSHING WAS DONE WITH INTRODUCER SHEATH PRIOR TO ADVANCING COILS. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-MAR-2025 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE MICROCATHETER WAS NOT REMOVED OR REPLACED DURING PROCEDURE. THE TARGET VESSEL WAS THE MIDDLE MENINGEAL ARTERY. THE DEVICE DID NOT APPEAR DAMAGED AT THE TIME OF PROCEDURE. THE DEVICES WERE NOT DAMAGED AFTER PROCEDURE WAS COMPLETE. THE DELIVERY WIRE WAS KINKED WHILE WE WERE INSPECTING INTRODUCER SHEATH. THE COILS NEVER PASSED THROUGH THE INTRODUCER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914000 ↗
• MalfunctionApr 25, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE FREEFORM MINI 1MM X 4CM COIL (MCR091040/31434946) "DID NOT DEPLOY CORRECTLY". THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-MAR-2025 INDICATED THAT THE PHYSICIAN USED AN SL-10 MICROCATHETER (NON-J&J). THE INTRODUCER SHEATH WAS SEATED INTO THE RHV AND THE EMBOLIC COIL WAS STARTED TO BE ADVANCED. RESISTANCE WAS MET AND THE PUSHER WIRE WAS PULLED BACK. THE COILS WERE ATTEMPTED TO BE ADVANCED THROUGH THE MICROCATHETER. IMMEDIATE RESISTANCE WAS MET; THEREFORE, THE COIL WAS PULLED OUT OF THE MICROCATHETER. OTHER TWO CEREPAK COILS WERE USED WITHOUT ISSUES. THE CAUSE OF DEPLOYMENT DIFFICULTY IS NOT KNOWN NOR SUSPECTED. THE CONCOMITANT DEVICES DID NOT APPEAR DAMAGED. THE PHYSICIAN STATED THAT THE COILS WERE NOT ADEQUATELY FLUSHED BEFORE ADVANCING THEM THROUGH THE MICROCATHETER. THE FOLLOWING 2 COILS WERE FLUSHED ADEQUATELY. THE COIL WAS REMOVED FROM THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL CEREPAK COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913700 ↗
• 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 19910852 ↗
• 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 19563951 ↗
• MalfunctionNov 8, 2023Fracture; Separation Failure; Fracture; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A SMALL ANTERIOR COMMUNICATING ARTERY (ACOM), A FREEFORM MINI 1MM X 4CM COIL (MCR091040, 31045747) WAS BEING PLACED AS THE 4TH COIL, HOWEVER, IT FAILED TO DETACH AFTER 2 ATTEMPTS WITH THE HANDLE. MANUAL DETACHMENT WAS ATTEMPTED AND PULL WIRE DID NOT MOVE BACK AFTER A 90-DEGREE BEND AS PER PREP/DELIVERY INSTRUCTIONS (PROXIMAL OUTER HYPOTUBE SLID OFF OF PULL WIRE). HEMOSTATS WERE UTILIZED ON PULL WIRE TO TRY AND PERFORM MANUAL DETACHMENT YET PULL WIRE DID NOT MOVE WITH THE PORTION CLAMPED ON SNAPPING AWAY. WE ADVISED THE PHYSICIAN TO THEN REMOVE COIL OUT OF SAFETY CONCERNS AND WAS RETRIEVED TO BE SENT FOR ANALYSIS. TWO MORE COILS WERE ATTEMPTED AND DETACHED PERFECTLY AFTER DEFECTIVE ONE WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS SUCCESSFUL COMPLETED. THE SURGERY WAS PROLONGED BY 10 MINUTES DUE TO THE EVENT, THE DELAY WAS NOT CLINICALLY SIGNIFICANT. UPON REMOVAL OF COIL TO BE SENT FOR INSPECTION, THE COIL WAS ATTEMPTED TO BE RE-SHEATHED ON THE BACK TABLE. AS THE COIL WAS ABOUT TO ENTER THE SHEATH AFTER THE DETACHMENT ZONE IT DEPLOYED ONTO THE TABLE. NO MORE FRICTION THAN NORMAL WAS REPORTED BY THE ASSISTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092644 ↗