CEREPAK FREEFORM SCR120620Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704083184), received between Apr 29, 2024 and Dec 2, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (1 report).

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 16, 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.

• MalfunctionDec 2, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2024, DURING A RETREATMENT OF A PREVIOUSLY COILED INTERNAL CAROTID ARTERY (ICA) TERMINUS ANEURYSM, THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST COIL, A 11MM X 18.9CM CEREPAK UNIFORM XL (FCX181118 / 31168333), WHEN HE WAS READY TO DETACH THE COIL VIA MECHANICAL DETACHMENT, THE COIL DID NOT DETACH. THE PHYSICIAN MADE ANOTHER UNSUCCESSFUL ATTEMPT. THE PHYSICIAN THEN IMPLANTED TWO SIMILAR SIZED COMPETITOR COILS. HE THEN ATTEMPTED TO DEPLOY TWO MORE CEREPAK COILS, AND THEY WORKED FINE. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY TWO MORE CEREPAK FREEFORM COILS, A 6MM X 20CM CEREPAK FREEFORM (SCR120620 / 31058141) AND A 6MM X 10CM CEREPAK FREEFORM (SCR120610 / 31146353) AND THEY DID NOT DETACH. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT OR DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821285 ↗
• MalfunctionApr 29, 2024Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE RIGHT CAROTID TERMINUS, THE PHYSICIAN HAD DETACHMENT ISSUES WITH A UNIFORM XL 10MM X 17.1 CM COIL (FCX181017, 31243967). THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) DID NOT BREAK. HE WAS ABLE TO GET IT TO DETACH BY PUSHING THE COIL PUSHER RAPIDLY IN AND OUT. THE NEXT COIL WAS A FREEFORM 9MM X 25 CM (SCR120925, 31173116), THE HANDLE DETACHMENT FAILED, AND HE THEN TRIED THE MANUAL BREAK, THIS ONE DETACHED. THEN A FREEFORM 6MM X 20 CM COIL (SCR120620, 31058141) WAS USED. THE HANDLE FAILED AND SO DID THE MANUAL BREAK. HE TRIED TO MAKE IT DETACH BY PUSHING THE COIL PUSHER IN AND OUT IN HOPES IT WOULD RELEASE. THE PHYSICIAN THEN TRIED TO REMOVE THE COIL, WHILE PULLING IT OUT OF THE ANEURYSM THE COIL DETACHED IN THE ECHELON 10 MICROCATHETER (MC). HE WAS ABLE TO PUSH THE COIL BACK INTO THE ANEURYSM WITH A MICROWIRE. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 16-APR-2024 INDICATING THAT THE UNIFORM XL 10MM X 17.1 CM COIL WAS THE FIRST COIL TO BE USED. THERE WAS NO RESISTANCE WHILE PUSHING THE COILS THROUGH THE MICROCATHETER; THERE WAS NO DIFFICULTY POSITIONING THE MICROCATHETER INTO THE ANEURYSM HOWEVER THERE WAS DIFFICULT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201419 ↗