CEREPAK FREEFORM XCR120408Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704083672), received between Dec 12, 2023 and Sep 5, 2024 — 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 5, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, CEREPAK COILS WERE BEING USED TO EMBOLIZE A VENUS FISTULA FEEDER. USING A CEREBASE GUIDE SHEATH, VECTA 46 CATHETER AND A SCEPTER XC BALLOON CATHETER TO INSERT COILS. WHEN USING THE MECHANICAL DETACHMENT HANDLE FOR A FREEFORM XSFT 3MM X 8 CM COIL (XCR120308, 31112709), THE HANDLE WAS MOVED TOO FAR LATERALLY/TOWARDS THE PHYSICIAN WHICH CAUSED THE MANUAL BREAK POINT AND PULL WIRE TO FRACTURE. THE PHYSICIAN BELIEVED IT WAS USER ERROR FOR MOVING THE PUSHER TUB/HANDLE. THE COIL WAS THEN REMOVED. NO DELAY OR PATIENT HARM OCCURRED. A FREEFORM XSFT 4MM X 8 CM COIL (XCR120408, LOT TO BE CONFIRMED) WAS PLACED BUT FAILED TO DETACH WITH MANUAL BREAK. THE MANUAL BREAK WAS INITIATED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER INITIAL BREAK AND PULL, THE COIL DIDN¿T DETACH. THE PHYSICIAN THEN PULLED A SECOND TIME, PULLING MANY CM OF WIRE. THE COIL STILL DIDN¿T DETACH. THE COIL WAS THEN REMOVED. NO PATIENT HARM OCCURRED AND NO SIGNIFICANT DELAYED OCCURRED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 19-AUG-2024 INDICATING THAT THE FREEFORM XSFT 3MM X 8 CM WAS THE FIRST COIL USED. WHEN THE FREEFORM XSFT 4MM X 8 CM COIL WAS USED, THERE HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20144072 ↗
• MalfunctionFeb 1, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY (ACCOM), TWO FREEFORM XSFT 4MM X 8 CM COILS ((B)(6)), A FREEFORM XSFT 3MM X 6 CM COIL ((B)(6)) AND A TWO FREEFORM XSFT 3MM X 4 CM COILS ((B)(6), LOT UNKNOW) AND ((B)(6)) WERE ADVANCED INTO ANEURYSM AND MANUAL DETACHMENT WAS ATTEMPTED WITH NO SUCCESS. THE COILS WERE REMOVED FROM THE PATIENT. THE FREEFORM XSFT 3MM X 4 CM COILS WERE PLACED INTO THE ANEURYSM AND DETACHMENT WAS ATTEMPTED WITH A MECHANICAL DETACHMENT HANDLE (MDH1) WITH NO SUCCESS. THE COILS WERE REMOVED FROM THE PATIENT. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 22-JAN-2024 INDICATED THAT A STRYKER SL-10 MICROCATHETER WAS USED. THREE COILS WERE SUCCESSFULLY DETACHED WITH MANUAL DETACHMENT PRIOR TO THE FAILURE, THEN TWO FAILURES WITH 4MM X 8 CM COIL, THEN A SUCCESSFUL DETACHMENT OF TWO 3MM X 6 CM, THEN A FAILED 3MM X 6 CM , THEN TWO MORE FAILED WITH 3MM X 4 CM WITH DETACHMENT HANDLE. 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 COILS OR ANY DEVICE COMPONENT. THERE WAS MILD TORTUOSITY. THE EVENT DID NOT RESULT IN ANY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625806 ↗
• MalfunctionFeb 1, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY (ACCOM), TWO FREEFORM XSFT 4MM X 8 CM COILS (XCR120408, 31126838), A FREEFORM XSFT 3MM X 6 CM COIL (XCR120306, 31136147) AND A TWO FREEFORM XSFT 3MM X 4 CM COILS (XCR120304, LOT UNKNOW) AND (XCR120304, 31131259) WERE ADVANCED INTO ANEURYSM AND MANUAL DETACHMENT WAS ATTEMPTED WITH NO SUCCESS. THE COILS WERE REMOVED FROM THE PATIENT. THE FREEFORM XSFT 3MM X 4 CM COILS WERE PLACED INTO THE ANEURYSM AND DETACHMENT WAS ATTEMPTED WITH A MECHANICAL DETACHMENT HANDLE (MDH1) WITH NO SUCCESS. THE COILS WERE REMOVED FROM THE PATIENT. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 22-JAN-2024 INDICATED THAT A STRYKER SL-10 MICROCATHETER WAS USED. THREE COILS WERE SUCCESSFULLY DETACHED WITH MANUAL DETACHMENT PRIOR TO THE FAILURE, THEN TWO FAILURES WITH 4MM X 8 CM COIL, THEN A SUCCESSFUL DETACHMENT OF TWO 3MM X 6 CM, THEN A FAILED 3MM X 6 CM , THEN TWO MORE FAILED WITH 3MM X 4 CM WITH DETACHMENT HANDLE. 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 COILS OR ANY DEVICE COMPONENT. THERE WAS MILD TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625647 ↗
• MalfunctionDec 12, 2023Break; Separation Failure; Break; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN INTERNAL CAROTID ARTERY (ICA)-OPHTHALMIC SEGMENT SIDE WALL ANEURYSM, THE FIRST COIL USED WAS A 4MM X 8CM CEREPAK FREEFORM XTRASOFT (XCR120408 / 31126838). IT WAS SUCCESSFULLY NAVIGATED AND INSERTED INTO THE ANEURYSM. DURING MANUAL DETACHMENT, THE PULL WIRE WAS BROKEN IN HALF. THE PHYSICIAN ADMITTED THAT IT WAS USER ERROR BECAUSE THE DISTAL PORTION OF THE HYPOTUBE WAS NOT ¿IN-LINE¿ WITH THE PROXIMAL PORTION WHEN PULLING TO DETACH THE COIL. THE DISTAL PORTION OF THE HYPOTUBE WAS AT AN ANGLE WHEN THE PULLING OCCURRED ¿ WHICH CAUSED THE PULL WIRE TO SNAP. THE COIL WAS SUCCESSFULLY REMOVED. TWO ADDITIONAL COILS WERE THEN PLACED AND SUCCESSFULLY DETACHED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 04-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT NO DETACHMENT HANDLE WAS USED; MANUAL BREAK WAS USED. THE MICROCATHETER USED WAS SL-10® MICROCATHETER (STRYKER); THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315597 ↗