CEREPAK FREEFORM SCR121230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704083252), received between Jul 16, 2024 and Nov 15, 2024 — 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.

• MalfunctionNov 15, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM, EIGHT (8) COILS WERE IMPLANTED WITHOUT FAIL. TWO COILS FAILED TO DETACH: THE TWO COILS ARE A 12MM X 30CM CEREPAK FREEFORM (SCR121230 / 31173118) AND A 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 / 31207074). IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 30-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ANEURYSM WAS AN UNRUPTURED SACCULAR ANEURYSM WITH A SIZE OF 11MM. THE DETACHMENT HANDLE (MDH1 / 102109430) WAS USED ON THE FIRST COIL, THE 12MM X 30CM CEREPAK FREEFORM (SCR121230 / 31173118) FOR ONE DETACHMENT ATTEMPT, WHEN THE COIL DID NOT DETACH, THEY SWITCHED TO MANUAL BREAK. THE 12MM X 30CM CEREPAK FREEFORM COIL STILL DID NOT DETACH. PER THE INFORMATION, MANUAL BREAK WAS THE PRIMARY METHOD OF DETACHMENT FOR ALL REMAINING COILS. THE DETACHMENT HANDLE IS NOT AVAILABLE FOR RETURN. WHEN THE 12MM X 30CM CEREPAK FREEFORM COIL WAS REMOVED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. WHEN THE 3MM X 6CM CEREPAK FREEFORM MINI (MCR093060 /

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700414 ↗
• MalfunctionJul 16, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, ATTEMPTS WERE MADE TO DETACH THE 12MM X 30CM CEREPAK FREEFORM COIL (SCR121230 / 31140716) WITH THE CEREPAK TM DETACHMENT HANDLE (MDH1 / LOT# UNKNOWN), THE COIL WOULD NOT RELEASE. THREE ATTEMPTS TO DETACH WERE MADE WITH THE DETACHMENT HANDLE FOLLOWED BY TWO ATTEMPTS TO DETACH VIA MANUAL BREAK TO NO AVAIL. THE COMPLAINT COIL WAS REMOVED AND ANOTHER COIL WAS USED AND IT ¿DETACHED FLAWLESSLY.¿ THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT; THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON 10-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION THE PROCEDURE WAS TARGETING A 13 MM X 12 MM X 11MM RUPTURED ANEURYSM ON THE RIGHT POSTERIOR COMMUNICATING (PCOM) ARTERY. THE LOT NUMBER OF THE DETACHMENT HANDLE WAS PROVIDED (102109430); THE HANDLE IS NOT AVAILABLE FOR RETURN. WHEN THE 12MM X 30CM CEREPAK FREEFORM COIL WAS REMOVED, IT WAS NOT STRETCHED AND IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE MICROCATHETER USED WAS AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THE REPLACEMENT COIL WAS A 12MM X 40CM CEREPAK UNIFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757566 ↗