CEREPAK FREEFORM XCR123509Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704083771), received between Jul 22, 2024 and Sep 15, 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 15, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A FREEFORM XSFT 3.5MM X 9 CM COIL (XCR123509, 31476102) WAS INSERTED AND USED MANUAL BREAK TO DETACH COIL. HOWEVER, THE COIL DID NOT DETACH. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 09-SEP-2025 INDICATED THAT A MICROVENTION HEADWAY DUO 156CM MICROCATHETER WAS USED. THERE WAS NO ATTEMPT MADE TO USE THE DETACHMENT HANDLE. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051515 ↗
• MalfunctionNov 7, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY (ACOM), A FREEFORM XSFT 3.5MM X 9 CM COIL (XCR123509, 31146355) WAS THE THIRD COIL TO BE INSERTED, HOWEVER DID NOT DETACH AFTER ATTEMPTING ONCE WITH A MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) AND MANUAL DETACHMENT 4 TIMES. THE COIL WAS REMOVED WITHOUT DIFFICULTY AND A NON J&J COIL WAS PLACED, DETACHED AND CASE WAS THEN COMPLETE. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-OCT-2024 INDICATED THAT TWO COILS WERE PREVIOUSLY IMPLANTED DURING PROCEDURE. THERE WAS ¿A LITTLE BACK AND FORTH BUT AFTER A COUPLE OF TIMES, COIL FIT IN ANEURYSM¿. THERE WAS SOME CATHETER BACKUP OR TIP DEFLECTION, BUT IT WAS MINIMAL. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THERE WAS NO VESSEL EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632118 ↗
• MalfunctionSep 6, 2024Stretched; Separation Failure; Stretched; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A VENOUS POUCH FOR A FISTULA, A FREEFORM XSFT 3.5MM X 9 CM COIL (XCR123509, 31146355) WAS USED THROUGH A HEADWAY DUO 167CM. THE MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) WAS USED FOR THE FIRST DETACHMENT ATTEMPTS. AFTER A FEW FAILED DETACHMENTS ATTEMPTS WITH THE HANDLE, THE MANUAL BREAK WAS USED WHICH ALSO FAILED. THE COIL WAS ATTEMPTED TO BE REMOVED BUT MET RESISTANCE. AT THAT POINT THE COIL AND MICROCATHETER (MC) WERE REMOVED AND IT WAS NOTED THAT THE COIL WAS TANGLED PREVENTING IT FROM BEING RECAPTURED IN THE MICROCATHETER. NO PATIENT HARM CAME FROM THIS EVENT. THE FISTULA WAS SUCCESSFULLY EMBOLIZED WITH THE SUCCESSFUL DEPLOYMENT OF KANEKA AND BALT COILS. MODERATE TORTUOSITY WAS NOTED IN THE FACIAL VEIN. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 28-AUG-2024 INDICATING THAT 15 PLUS COILS (KANEKA AND BALT OPTIBLOCK) WERE USED PRIOR TO USING THE CEREPAK COIL. THERE WAS NO DIFFICULTY IN ADVANCING THE DEVICE OR POSITIONING OF THE MICROCATHETER IN THE FISTULA. THERE WAS NO DAMAGE TO THE DEVICE DURING REMOVAL FROM THE COIL HOOP OR DURING THE INSERTION OR FEEDING THE COIL INTO THE MICROCATHETER. NO DAMAGE OCCURRED TO ANY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157804 ↗
• MalfunctionJul 22, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. THE PROXIMAL ANATOMY WAS TORTUOUS IN CAROTID ARTERY. AN INTERMEDIATE VECTA 071 CATHETER WAS USED, TWO SL 10 MICROCATHETERS WERE PLACED AND AN ATLAS STENT PLACEMENT. THE FIRST COIL, A FREEFORM XSFT WAS DEPLOYED AND DETACHED USING THE DETACHER WITHOUT DIFFICULTY. A SECOND COIL, A FREEFORM XSFT 3.5MM X 9 CM (XCR123509, 31173120) AND A THIRD COIL, A FREEFORM XSFT 3MM X 8 CM (XCR120308, 31112709) WERE DEPLOYED BUT DID NOT DETACH. EACH USING MECHANICAL DETACHMENT HANDLER (MDH1, LOT UNKNOWN) FIRST AND MANUAL BREAK SECOND. THE PHYSICIAN COMPLETED THE CASE USING 8 MORE STRYKER COILS ALL DETACHING WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19800368 ↗