CEREPAK FREEFORM SCR120410Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704083122), received between Jul 9, 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. 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 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 21953786 ↗
• MalfunctionJul 9, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, TWO COILS ¿ A 4MM X 10CM CEREPAK FREEFORM ((B)(6)) AND A 4MM X 7CM CEREPAK FREEFORM ((B)(6)) WOULD NOT DETACH ONCE DEPLOYED IN A CEREBRAL ANEURYSM. THE COILS WERE SUCCESSFULLY REMOVED WITHOUT ANY NEGATIVE IMPACT TO THE PATIENT. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED WITH THE PATIENT SUCCESSFULLY TREATED WITH DIFFERENT COILS. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUES. ON 09-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE LOCATION OF THE TARGET ANEURYSM WAS THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE ATTEMPTS TO DETACH THE COILS WERE MADE USING THE DETACHMENT HANDLE AS WELL AS MECHANICAL BREAK. THE CATALOG AND LOT NUMBER OF THE DETACHMENT HANDLE USED WAS (B)(6). THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED. BOTH COILS WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS WHEN THEY WERE REMOVED. THE MICROCATHETER USED WAS A PROWLER SELECT LPES ((B)(6)). THE INFORMATION INDICATED THAT THE COILS WERE NOT REPLACED WITH COILS FROM THE SAME PRODUCT CODES OR DIFFERENT BRANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707392 ↗