CEREPAK FREEFORM XCR122505Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704083733), received between Jun 3, 2024 and May 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 21953814 ↗
• MalfunctionNov 5, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED BASILAR TIP ANEURYSM, THE PHYSICIAN EXPERIENCED DETACHMENT ISSUES WITH THREE CEREPAK COILS: A 5MM X 17CM CEREPAK UNIFORM (FCX100517 / 31127138), THIS WAS THE 7TH COIL USED IN THE PROCEDURE, A 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167), THIS WAS THE 15TH COIL USED IN THE PROCEDURE, AND THE 16TH COIL, ANOTHER 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167). IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PLACE THE COILS THROUGH AN SL-10® MICROCATHETER (STRYKER) MICROCATHETER. THEN ONCE THE COILS WERE ADVANCED INTO POSITION, THE PHYSICIAN HOOKED UP TO THE DETACHMENT HANDLE (MDH1 / LOT# UNKNOWN) AND ATTEMPT TO DETACH. FOR EACH OF THE THREE COILS, AFTER THE FIRST ATTEMPTED DETACHMENT, THE PHYSICIAN NOTED THAT THE COILS HAD NOT DETACH AND HE REATTACHED THE COILS TO THE DETACHMENT HANDLE AND MADE SECOND UNSUCCESSFUL ATTEMPT TO DETACH THE COILS. IT WAS REPORTED THAT THE COILS WERE REMOVED, AND THE PHYSICIAN CONTINUED WITH THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY. ON 24-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605959 ↗
• MalfunctionJun 3, 2024Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A RIGHT (RT) SUPERIOR CEREBELLAR ARTERY (SCA) ANEURYSM, THE FIRST COIL, A FREEFORM XSFT 2.5MM X 5 CM COIL (XCR122505, 31077167) FAILED TO DETACH USING THE MANUAL BREAK TECHNIQUE. THE TECHNOLOGIST RESPONSIBLE FOR THE DETACHMENT PERFORMED THE MANUAL BREAK TECHNIQUE AS PER THE IN-SERVICE THAT WAS CONDUCTED FOR THE PHYSICIANS AND STAFF. ENSURED THAT THE DELIVERY SYSTEM WAS STRAIGHT DURING THE DETACHMENT PROCESS. IT WAS OBSERVED THAT THE COIL FAILED TO DETACH WHEN REMOVING THE DELIVERY SYSTEM UNDER FLUORO. THE COIL WAS ADVANCED INTO THE ANEURYSM FOR A SECOND DETACHMENT ATTEMPT. THE COIL FAILED TO DETACH FOR A SECOND TIME AND THE COIL WAS REMOVED BUT DURING THE REMOVAL OF THE COIL IT DETACHED WHILE A PORTION OF THE COIL WAS IN THE CATHETER AND THE OTHER EXTENDING OUTSIDE OF THE MICROCATHETER (MC). BOTH MICROCATHETER AND COIL WERE REMOVED. NO PATIENT HARM OCCURRED DURING THE EMBOLIZATION OF THE RT SCA ANEURYSM. THE PHYSICIAN WAS ABLE TO EMBOLIZE THE ANEURYSM WITH ANOTHER CEREPAK FREEFORM XSFT 2.5MM X 5CM. THERE WAS MILD TO MODERATE TORTUOSITY. LEFT FEMORAL ACCESS, BMX 81, 5F SOFIA, AND SL10 MICROCATHETER. ADDITIONAL EVENT INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446927 ↗