CEREPAK UNIFORM FCX100407Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704084013), received between Aug 27, 2024 and Sep 4, 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 4, 2025Material Separation; Separation Failure; Material Separation; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO AN UNKNOWN VESSEL, THE PHYSICIAN USED A UNIFORM 4MM X 7.5 CM COIL (FCX100407, 31154117). THEY TRIED TWICE TO DETACH THE COIL WITH A MECHANICAL DETACHMENT HANDLE (MDH1, LOT UNKNOWN) AND IT FAILED TO DETACH. ON THIRD TRY, IT SEEMS THE PROXIMAL WIRE OF THE COIL (THE PART INSIDE DETACHER) BROKE OFF. THE COIL DID NOT DETACH, AND THEY TOOK IT OUT OF THE PATIENT. THE PIECE THAT HOSPITAL CLAIMS TO HAVE BROKEN OFF AND THE DETACHER WERE NOT SAVED AND ONLY THE COIL WILL BE RETURNED FOR ANALYSIS. ADDITIONAL EVENT INFORMATION RECEIVED ON 03-SEP-2025 INDICATED THAT THIS WAS THE FIRST COIL THEY TRIED TO USE. THERE WAS NO RESISTANCE MENTIONED. THERE WAS NO REPORT OF EMBOLIC COIL DAMAGE. THERE WAS NO MENTION OF ANY COMPLEXITY WITH ANATOMY OR PATIENT. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963014 ↗
• MalfunctionMar 31, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION IN A VERY TORTUOUS MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION CASE THAT INCLUDED A LOOP IN THE DISTAL INTERNAL CAROTID ARTERY (ICA), TWO UNIFORM 4MM X 7.5 CM COILS (FCX100407, 31484777) DID NOT DETACH IN THE ANEURYSM. THE SYSTEM WAS STRAIGHT OUTSIDE THE BODY. IT DOES SEEM TO HAVE SOME NOTABLE TORTUOSITY DISTAL TO THE TIP OF THE SHEATH IN THE RIGHT FEMORAL ACCESS. BOTH COILS WERE TAKEN OUT OF THE BODY WITHOUT ISSUES AND DID NOT CAUSE ANY NEGATIVE IMPACTS TO THE PATIENT. THESE ARE THE ONLY CEREPAK COILS USED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731366 ↗
• MalfunctionMar 31, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION IN A VERY TORTUOUS MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION CASE THAT INCLUDED A LOOP IN THE DISTAL INTERNAL CAROTID ARTERY (ICA), TWO UNIFORM 4MM X 7.5 CM COILS (FCX100407, 31484777) DID NOT DETACH IN THE ANEURYSM. THE SYSTEM WAS STRAIGHT OUTSIDE THE BODY. IT DOES SEEM TO HAVE SOME NOTABLE TORTUOSITY DISTAL TO THE TIP OF THE SHEATH IN THE RIGHT FEMORAL ACCESS. BOTH COILS WERE TAKEN OUT OF THE BODY WITHOUT ISSUES AND DID NOT CAUSE ANY NEGATIVE IMPACTS TO THE PATIENT. THESE ARE THE ONLY CEREPAK COILS USED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731349 ↗
• MalfunctionAug 27, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN ATTEMPTED TO DETACH A UNIFORM 4MM X 7.5 CM COIL (FCX100407, 31154117) AND A FREEFORM 4MM X 7 CM COIL (SCR120407, 31149189), HOWEVER, BOTH COILS WOULD NOT DETACH. HE WAS ABLE TO GAIN ACCESS TO THE ANEURYSM PROPERLY AND DEPLOY THE CEREPAK COILS. ONCE THE COIL WAS IN PLACE PROPERLY, HE ATTEMPTED TO DETACH THE COIL USING A MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) AND NOTHING HAPPENED. HE THEN ATTEMPTED TO MANUALLY BREAK. HE DID A TEXTBOOK MANUAL BREAK AND THE COIL DID NOT DETACH. HE THEN HAD TO REMOVE THE COIL. THE SECOND ATTEMPT WITH THE SECOND COIL WENT EXACTLY THE SAME. HE FIRST ATTEMPTED TO USE THE DETACHER. IT DID NOT DETACH SO HE THEN ATTEMPTED TO MANUALLY BREAK. IT DID NOT BREAK. THE COILS WERE REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075974 ↗