CEREPAK HELIFORM XHE120206Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704083948), received between Dec 27, 2024 and May 2, 2025 — classified as 2 malfunctions.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CAROTID ARTERY PROCEDURE, THE FOLLOWING COILS WERE ADVANCED THROUGH THE EXCELSIOR SL-10® MICROCATHETER (STRYKER) INTO THE FACIAL ARTERY WITHOUT ISSUES: 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31107820), 4MM X 10CM CEREPAK FREEFORM XSFT (XCR120410 / 31112708), 4MM X 10CM CEREPAK FREEFORM (SCR120410 / 31177726), 2MM X 6CM CEREPAK FREEFORM MINI (MCR092060 / 31459691), 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167), 2MM X 6CM CEREPAK HELIFORM XTRASOFT XL (XHE120206 / 31216620), AND 2MM X 8CM CEREPAK HELIFORM XSFT (XHE120208 / 31361855). FLUSH LINE WAS RUNNING. THE DISTAL ANATOMY WAS EXTREMELY TORTUOUS. THE PROXIMAL PORTION OF THE SYSTEM WAS STRAIGHT, AND MANUAL DETACHMENT WAS ATTEMPTED FIRST WITH THE DETACHMENT HANDLE (MDH1 / 102109430) AND THEN WAS SHIFTED TO MANUAL BREAK WITHOUT ANY SUCCESSFUL DETACHMENT. IT WAS REPORTED THAT OTHER CEREPAK COILS AND STRYKER COILS WERE BOTH PLACED BEFORE AND AFTER THESE COILS WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 30-APR-2025, RESPONSES TO ADDITIONAL INFORMATION REQUESTS WERE RECEIVED. PER THE ADDITIONAL INFORMATION, TWO DETACHMENT HANDLES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953744 ↗
• MalfunctionDec 27, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION OF THE MIDDLE MENINGEAL ARTERY (MMA) WITH MILD TORTUOSITY NOTED IN THE LATERAL EXTERNAL CAROTID ARTERY (LECA) AND THE LEFT MMA, A 2MM X 6CM CEREPAK HELIFORM XTRASOFT XL (XHE120206 / 31393529) WAS USED THROUGH A PLATO® 17 MICROCATHETER (SCIENTIA VASCULAR). THE DETACHMENT HANDLE (MDH1 / LOT# UNKNOWN) WAS USED FOR THE FIRST TWO DETACHMENT ATTEMPTS. AFTER THE FAILED DETACHMENT ATTEMPTS WITH THE HANDLE, THE MANUAL BREAK METHOD WAS USED, WHICH ALSO FAILED. THE COIL WAS REMOVED, AND ANOTHER COIL OF THE SAME SIZE WAS USED WITH SUCCESS. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT NOR ANY DELAY IN THE PROCEDURE. THE LEFT MMA WAS SUCCESSFULLY EMBOLIZED WITH TWO MORE CEREPAK COILS. ON 27-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION THE LOT NUMBER OF THE DETACHMENT HANDLE IS NOT KNOWN. WHEN THE COIL WAS REMOVED FROM THE PATIENT, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. ¿THE COIL WAS INSPECTED ON THE BACK TABLE AND THERE WAS NO VISIBLE DAMAGE TO THE DELIVERY SYSTEM THAT COULD HAVE CONTRIBUTED TO THE DETACHMENT FAILURE.¿ THE COIL WAS NOT STRETCHED. THERE WAS NO EVIDENCE OF BLOOD FLOW IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027290 ↗