CEREPAK FREEFORM MCR091540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704082989), received between Jun 18, 2024 and Sep 16, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO THE MENINGEAL ARTERY, THE SCRUB NURSE FELT RESISTANCE WITH A FREEFORM MINI FREEFORM MINI 1.5MM X 4CM COIL (MCR091040, 31585344) WHILE PUSHING IN THE COIL INTO THE PINK SHEATH. COIL REMOVED FROM RHV, AND CHECKED, IT WAS NOT MOVING FORWARD. 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 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. BASED ON THE PRODUCT ANALYSIS OF THE FREEFORM MINI 1.5MM X 4CM RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED AND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062600 ↗
• InjuryAug 28, 2025Break; Difficult to Advance; Premature Separation; Break; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2025, DURING AN ENDOVASCULAR EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY (MMA) TO TREAT A PATIENT WITH CHRONIC SUBDURAL HEMATOMA (CSDH), AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS NAVIGATED TO THE TREATMENT AREA AND A 1.5MM X 4CM CEREPAK FREEFORM MINI (MCR091540 / 31136066) WAS INSERTED INTO THE MICROCATHETER, PLACED INTO THE DESIRED ARTERY AND WAS READY TO BE DETACHED WHEN IT WAS NOTICED THAT THE PROXIMAL (OUTSIDE THE BODY) MICROCATHETER AND COIL WERE NOT STRAIGHT; THIS WAS UNSUITABLE FOR COIL DETACHMENT. THE PHYSICIAN WAS DIRECTED TO STRAIGHTEN THE UNI. UPON DOING THIS, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE MICROCATHETER HAD BEEN PULLED BACK TO AN UNDESIRABLE LOCATION. THE COIL NEEDED TO BE RESHEATHED IN ORDER TO REMOVE IT TO REDIRECT THE MICROCATHETER. IT WAS REPORTED THAT AT THIS TIME, THE 1.5MM X 4CM CEREPAK FREEFORM MINI COIL WAS NOTICED TO HAVE BECOME PREMATURELY DETACHED AND NEEDED TO BE RETRIEVED. THE COIL WAS SUCCESSFULLY RETRIEVED USING A SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE IMPACT TO THE PATIENT. THE PROCEDURE WAS DELAYE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917600 ↗
• MalfunctionMar 19, 2025Separation Failure; Separation Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, THIS WAS A COIL EMBOLIZATION OF A LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM THAT HAD RECANALIZED FROM A PRIOR CLIPPING PROCEDURE. THE FOLLOWING THREE CEREPAK COILS DETACHED: FCX100412, SCR122505 AND XCR120202. THE FOURTH/FINAL COIL, A FREEFORM MINI 1.5MM X 4CM (MCR091540, (B)(6)) FAILED TO DETACH. THE PHYSICIAN WAS USING THE MANUAL BREAK METHOD. MICROCATHETER USED WAS AN SL-10, STENT WAS AN ATLAS. THERE WERE NO PROCEDURAL DELAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-MAR-2025 INDICATED THAT THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THERE WAS NO PATIENT INJURY. AFTER THE COIL DID NOT DETACH, THE USER DECIDED TO STOP ADDING ANY MORE COILS. THE PHYSICIAN IS UNSURE OF CAUSED THE FAILURE TO DETACH. HE HAS APPROXIMATELY 20 CEREPAK COILS AND HAS NEVER HAD AN ISSUE BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642805 ↗
• MalfunctionAug 2, 2024Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE MIDDLE MENINGEAL ARTERY (MMA), THE PHYSICIAN WAS COILING LEFT MAIN TRUNK OF MMA. A HELIFORM XSFT XL 2MM X 8 CM COIL WAS PLACED. THEN THE USER ASKED FOR A SECOND HELIFORM XSFT XL 2MM X 8 CM COIL (XHE120208, 31118010). AS THE EXPERIENCED TECHNOLOGIST WAS ADVANCING THIS COIL THROUGH THE INTRODUCER SHEATH, WHEN SHE REACHED THE FRACTURE POINT OF THE MANUAL BREAK, THE MANUAL BREAK FRACTURED. THERE WAS NO EXCESSIVE FORCE, EVERYTHING WAS MOVING SMOOTHLY. IT WAS NOT HER FIRST TIME USING THE PRODUCT. REMOVED THIS COIL FROM THE MICROCATHETER SYSTEM AND REOPENED ANOTHER COIL AND SUCCESSFULLY PLACED TWO MORE COILS ON THE LEFT SIDE. ON THE RIGHT SIDE HE ALSO WANTED TO COIL THE RIGHT MAIN TRUNK OF THE MMA. HE PLACED 2 AVENIR COILS SUCCESSFULLY. THEN AS THE TECHNOLOGIST WAS ADVANCING A FREEFORM MINI 1.5MM X 4CM COIL (MCR091540, 31136066) THROUGH THE INTRODUCER SHEATH, AT THE FRACTURE POINT OF THE MANUAL BREAK, IT AGAIN BROKE. AGAIN, IT WAS NOTED SHE WAS ADVANCING SMOOTHLY AND SOFTLY- NO FORCE WAS OBSERVED. REMOVED COIL FROM MICROCATHETER SYSTEM, AND A NEW 1.5X4 MINI WAS SUCCESSFULLY PLACED. THE MICROCATHETERS USED FOR BOTH OF THESE INSTAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19893257 ↗
• 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 19563950 ↗