CEREPAK FREEFORM XCR122535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704083757), received between Nov 4, 2024 and Jan 6, 2025 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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 16, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJan 6, 2025Positioning Failure; Separation Failure; Positioning Failure; Separation Failure

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN UNKNOWN CEREPAK COIL (PRODUCT CODE/LOT # UNKNOWN) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THE COIL FAILED TO DETACH. THE EVENT RESULTED IN THE PHYSICIAN USING A BALLOON GUIDE CATHETER (UNKNOWN BRAND) TO ARREST BLOOD FLOW AND REMOVE THE COIL. COMPETITOR COILS WERE USED TO COMPLETE THE SURGERY. THE REPORTED BELIEVED THE ¿PATIENT DID END UP RE RUPTURING DURING THE CASE.¿ THE EVENT WAS REPORTED AS SUCH, ¿SURGEON CALLED ME ON SATURDAY 12-14-24 AT 4:22PM EST TO LET ME KNOW HE WOULD BE USING A CEREPAK FREEFORM MINI COIL TO TREAT A RUPTURED ACOM ANEURYSM. HE MENTIONED OVER THE PHONE HE DID NOT HAVING ANY DETACHERS AVAILABLE AND THAT HE WOULD NEED TO USE MANUAL BREAK AS A MECHANISM OF DETACHMENT. DR. CALLED ME BACK AT 5:22PM TO LET ME KNOW HE WAS HAVING AN ISSUE, AND HE COULDN¿T GET THE COIL DETACHED. ONCE THE COIL WAS INSIDE THE DOME OF THE ANEURYSM, THE MANUAL BREAK DETACHMENT FAILED. WITH THE COIL ALREADY IN THE ANEURYSM PROTECTING THE RUPTURE SITE HE WAS TRYING TO AVOID TAKING THE COIL OUT BECAUSE THE PATIENT COULD END UP RE RUPTURING. DR. OPTED TO PUT UP A BALLOON AND TAKE THE C

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 21081830 ↗
• MalfunctionNov 4, 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 20605717 ↗