CEREPAK FREEFORM XCR120306Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704083641), received between Feb 1, 2024 and Mar 6, 2025 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 2, 2025Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Material Separation; Material Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE HYPO TUBE OF A FREEFORM XSFT 3MM X 6 CM COIL (XCR120306, 31445669) SLIPPED OFF THE BACK WHEN MANUAL DETACHMENT HAPPENED. COIL STILL DETACHED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-MAR-2025 INDICATING THAT THE UNRUPTURED ANEURYSM WAS AT MIDDLE CEREBRAL ARTERY, M1 SEGMENT. THE DEVICE WAS NOT INADVERTENTLY SUBJECTED TO FORCE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537471 ↗
• MalfunctionDec 26, 2024Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 6CM CEREPAK FREEFORM XTRASOFT (XCR120306 / 31092859) DETACHED ¿FLAWLESSLY.¿ IT WAS THEN REPORTED THAT ¿IT SEEMED LIKE THE COIL POSITIONING MARKER WAS LEFT BEHIND.¿ THE MICROCATHETER (UNSPECIFIED BRAND) WAS REMOVED AND REPLACED. THERE WAS NO NEGATIVE PATIENT IMPACT. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. ON 18-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET OF THE PROCEDURE WAS THE INTERNAL CAROTID ARTERY (ICA). RELATED TO THE POSITIONING MARKER THAT REPORTEDLY WAS LEFT BEHIND, THE INFORMATION STATES, ¿IT SEEMED TO BE ABOUT 3-4 INCHES OF "WIRE" WHEN SPEAKING TO THE TECH. NEAR WHERE THE POSITIONING MARKERS WOULD BE.¿ THE MARKER WAS IN THE MICROCATHETER AND THE MICROCATHETER WAS REMOVED AND REPLACED. THE CONCOMITANT MICROCATHETER USED WAS AN SL-10® MICROCATHETER (STRYKER); THE REPLACEMENT WAS ANOTHER SL-10® MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019970 ↗
• MalfunctionMay 6, 2024Separation Failure; Premature Separation; Separation Failure; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA), A FREEFORM XSFT 3MM X 6 CM COIL (XCR120306, 31111679) DID NOT DETACHED PROPERLY. REMOVED FROM ANEURYSM AND THE COIL DETACHED INSIDE THE MARKSMAN 160CM MICROCATHETER (MC). THE MICROCATHETER AND COIL WERE REMOVED FROM THE PATIENT¿S BODY. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT BY 20 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 02-MAY-2024 INDICATING THAT ONE COIL HAD BEEN PREVIOUSLY 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, LOT UNKNOWN). THE VESSEL WAS EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THE PHYSICIAN DID NOT FEEL THAT THE REPORTED 20 MINUTES PROCEDURAL DELAY WAS CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248551 ↗
• MalfunctionApr 1, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH NORMAL VESSEL, STRAIGHT WITH NO BENDS, THE PHYSICIAN PLACED AND DETACHED VIA A DETACHMENT HANDLE (MDH1 / LOT# 101456956) SEVERAL CEREPAK COILS VIA AN SL-10® MICROCATHETER (STRYKER) WITH FLUSH LINE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY TWO (2) 3MM X 6CM CEREPAK FREEFORM XTRASOFT COILS (XCR120306) FROM THE SAME LOT (31092859) THE COILS FAILED TO DETACH. THE PHYSICIAN REMOVED COILS AND CONTINUED TO PLACE SIX (6) MORE COILS. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 21-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ANEURYSM WAS AN OBLONG 12MM X 9MM IN SIZE. THE LOT NUMBER OF THE DETACHMENT HANDLE WAS 101456956. WHEN THE 3MM X 6CM CEREPAK FREEFORM XTRASOFT WERE REMOVED, THEY WERE NOT STRETCHED; THE COIL WERE BOTH STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS. THE TWO COILS WERE REMOVED WITHOUT ISSUES. THE SUBSEQUENT SIX COILS WERE PLACED VIA THE SAME SL-10 MICROCATHETER; THE ADDITIONAL SIX COILS WERE NOT CEREPAK COILS, THEY WERE STRYKER COILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY CLINICALLY SIGNIFICA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016495 ↗
• MalfunctionApr 1, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH NORMAL VESSEL, STRAIGHT WITH NO BENDS, THE PHYSICIAN PLACED AND DETACHED VIA A DETACHMENT HANDLE (MDH1 / LOT# 101456956) SEVERAL CEREPAK COILS VIA AN SL-10® MICROCATHETER (STRYKER) WITH FLUSH LINE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY TWO (2) 3MM X 6CM CEREPAK FREEFORM XTRASOFT COILS (XCR120306) FROM THE SAME LOT (31092859) THE COILS FAILED TO DETACH. THE PHYSICIAN REMOVED COILS AND CONTINUED TO PLACE SIX (6) MORE COILS. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 21-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ANEURYSM WAS AN OBLONG 12MM X 9MM IN SIZE. THE LOT NUMBER OF THE DETACHMENT HANDLE WAS 101456956. WHEN THE 3MM X 6CM CEREPAK FREEFORM XTRASOFT WERE REMOVED, THEY WERE NOT STRETCHED; THE COIL WERE BOTH STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS. THE TWO COILS WERE REMOVED WITHOUT ISSUES. THE SUBSEQUENT SIX COILS WERE PLACED VIA THE SAME SL-10 MICROCATHETER; THE ADDITIONAL SIX COILS WERE NOT CEREPAK COILS, THEY WERE STRYKER COILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY CLINICALLY SIGNIFICA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016493 ↗
• 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 18625666 ↗