CEREPAK UNIFORM FCX100626Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704084051), received between May 8, 2025 and May 8, 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 8, 2025Separation Failure; Separation Failure

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT FIVE CEREPAK UNIFORM COILS WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE: UNIFORM 7MM X 30 CM (FCX100730/ 31127140), UNIFORM 7MM X 30 CM (FCX100730/ 31207071), UNIFORM 6MM X 26 CM (FCX100626/ 31177724), UNIFORM 6MM X 26 CM (FCX100626/ 31173105), A UNIFORM XL 5MM X 10 CM (FCX180510/ 31178183), AND A MECHANICAL DETACHMENT HANDLE (MDH1/ LOT # UNKNOWN). DURING THE PROCEDURE, THE USER REPORTED FAILURE TO DETACH FOR ALL FIVE COILS. THE PHYSICIAN FELT THE FAILURE TO DETACH WAS DUE TO PATIENT TORTUOUS ANATOMY. IT WAS ALSO REPORTED, ¿ONE COIL IS PARTIALLY HANGING IN ICA AROUND SITE.¿ ADDITIONAL INFORMATION WAS RECEIVED ON 29-APR-2025. SUMMARY: PER THE INFORMATION, THE MICROCATHETER WAS A PROWLER LPES (PRODUCT CODE/ LOT # UNKNOWN). REGARDING WHAT IS MEANT BY ¿ONE COIL IS PARTIALLY HANGING IN ICA AROUND SITE,¿ IT WAS REPORTED,¿ ONE COIL DID DETACH ONCE THE SYSTEM RELAXED AND WAS NOT UNDER SO MUCH TENSION.¿ ONE COIL WAS SUCCESSFULLY IMPLANTED DURING THIS CASE. REGARDING WHETHER RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICES THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM, IT WAS REPORTED, ¿MUCH TENSIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987172 ↗
• MalfunctionMay 8, 2025Separation Failure; Separation Failure

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT FIVE CEREPAK UNIFORM COILS WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE: UNIFORM 7MM X 30 CM (FCX100730/ 31127140), UNIFORM 7MM X 30 CM (FCX100730/ 31207071), UNIFORM 6MM X 26 CM (FCX100626/ 31177724), UNIFORM 6MM X 26 CM (FCX100626/ 31173105), A UNIFORM XL 5MM X 10 CM (FCX180510/ 31178183), AND A MECHANICAL DETACHMENT HANDLE (MDH1/ LOT#: UNKNOWN). DURING THE PROCEDURE, THE USER REPORTED FAILURE TO DETACH FOR ALL FIVE COILS. THE PHYSICIAN FELT THE FAILURE TO DETACH WAS DUE TO PATIENT TORTUOUS ANATOMY. IT WAS ALSO REPORTED, ¿ONE COIL IS PARTIALLY HANGING IN ICA AROUND SITE.¿ ADDITIONAL INFORMATION WAS RECEIVED ON 29-APR-2025. SUMMARY: PER THE INFORMATION, THE MICROCATHETER WAS A PROWLER LPES (PRODUCT CODE/ LOT#: UNKNOWN). REGARDING WHAT IS MEANT BY ¿ONE COIL IS PARTIALLY HANGING IN ICA AROUND SITE,¿ IT WAS REPORTED,¿ ONE COIL DID DETACH ONCE THE SYSTEM RELAXED AND WAS NOT UNDER SO MUCH TENSION.¿ ONE COIL WAS SUCCESSFULLY IMPLANTED DURING THIS CASE. REGARDING WHETHER RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICES THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM, IT WAS REPORTED, ¿MUCH TENSIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987155 ↗