CEREPAK FREEFORM XCR123505Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704083764), received between Feb 9, 2024 and Sep 2, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO THE ANTERIOR CEREBRAL ARTERY, A FREEFORM XSFT 3.5MM X 5 CM COIL (XCR123505, 31146338) FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT BY 15-20 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-AUG-2025 INDICATED THAT A PROWLER 14 MICROCATHETER WAS USED. THIS WAS THE FIRST COIL TO BE IMPLANTED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. TWO ATTEMPTS WERE MADE USING THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430). THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE 15 TO 20 MINUTES PROCEDURAL DELAY DID NOT RESULT IN ANY ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939404 ↗
• MalfunctionAug 12, 2025Material Separation; Separation Failure; Material Separation; Separation Failure

  IT WAS REPORTED, VIA HEALTHCARE PROFESSIONAL, THAT A UNIFORM 5MM X 17 CM (FCX100517/ 31127138) AND A FREEFORM XSFT 3.5MM X 5 CM (XCR123505/ LOT # UNKNOWN) WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED EMBOLIC COIL-FAILURE TO DETACH AND CEREPAK DELIVERY TUBE - SEPARATION DURING USE. WHILE ATTEMPTING TO PLACE THE UNIFORM 5MM X 17 CM EMBOLIC COIL, THE PULL WIRE ¿SNAPPED¿ WHEN PULLING BACK ON THE HYPOTUBE DURING MECHANICAL BREAK DETACHMENT, AND THE COIL WOULD NOT DETACH. THE COIL WAS SUBSEQUENTLY REMOVED, AND A UNIFORM 5X10 COIL WAS USED INSTEAD, WHICH SUCCESSFULLY DETACHED, HOWEVER, ¿THE PROCESS WAS NOT SMOOTH.¿ A THIRD COIL, THE FREEFORM XSFT 3.5MM X 5 CM, WAS THEN ATTEMPTED WITHIN THE ANEURYSM, BUT DURING A PRE-DETACHMENT RUN, THE PHYSICIAN SUSPECTED A RUPTURE. HE PROCEEDED TO DETACH THE COIL, HOWEVER, IT WOULD NOT DETACH, AND THE PULL WIRE SNAPPED WHEN PERFORMING MECHANICAL BREAK. THE COIL WAS REMOVED, AND THE SUSPECTED RUPTURE WAS MANAGED WITH BALLOON ANGIOPLASTY, WHICH WAS SUCCESSFUL. THE PHYSICIAN ASSESSMENT OF EVENTS WAS REPORTED AS SUCH, ¿HE¿S NOT SURE IF IT EVEN WAS A RUPT

  Patient problems: No Clinical Signs, Symptoms or Conditions; Ruptured Aneurysm

  MAUDE report 22785941 ↗
• 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 18691775 ↗
• MalfunctionFeb 9, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING THE BASILAR ARTERY ANEURYSM, AFTER SUCCESSFULLY PLACING ONE COIL, FOUR (4) ADDITIONAL COILS WERE USED WITH FAILED DETACHMENTS USING THE MANUAL BREAK. THE FOUR (4) COILS THAT HAD FAILED DETACHMENT ATTEMPTS WERE: A 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / (B)(6)), A 4MM X 6CM CEREPAK FREEFORM XSFT (XCR120406 / (B)(6)), A 4MM X 8CM CEREPAK FREEFORM XTRASOFT (XCR120408 / (B)(6)), AND A 3MM X 8CM CEREPAK FREEFORM XSFT (XCR120308 / (B)(6)). THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; THEY WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS WHEN THEY WERE REMOVED FROM THE PATIENT. THE PHYSICIAN DECIDED TO CONTINUE WITH THE DETACHER HANDLE AND SUCCESSFULLY DETACHED TEN (10) MORE COILS. THE PHYSICIAN USED A STRAIGHT SL-10® MICROCATHETER (STRYKER) WITH FLUSH LINES. IT WAS REPORTED THAT THE SYSTEM WAS STRAIGHTENED WITH NO BENDS PRIOR TO DETACHMENTS. THE SL-10® MICROCATHETER WAS USED THROUGH THE ENTIRE PROCEDURE TO ITS SUCCESSFUL CONCLUSION. THERE WAS NO PROCEDURE DELAY REPORTED AS A RESULT OF THE FAILED DETACHMENT ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681831 ↗