CEREPAK UNIFORM FCX100730Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704084075), received between Jun 12, 2023 and May 8, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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.

• 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 21987276 ↗
• 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 21987253 ↗
• MalfunctionApr 26, 2024Fracture; Fracture

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION TO A LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOMM) WITH HIGH TORTUOSITY. THE PHYSICIAN ATTEMPTED TO COIL ANEURYSM INITIALLY WITH ONLY COILS. FIRST COIL WAS A UNIFORM 7MM X 30 CM (FCX100730, 31127140). THIS SPECIFIC ANEURYSM HAD A LEDGE TOWARDS THE NECK OF THE ANEURYSM THAT CAUSED A HEADWAY DUO 156CM MICROCATHETER (MC) TO BECOME UNSTABLE. BECAUSE OF THE LEDGE, BECAUSE OF THE FORCE NEEDED TO ADVANCE THE COIL INTO THE ANEURYSM, THE COIL FRACTURED AT THE JUNCTION OF THE COIL AND THE PUSHER WIRE. THE 5 FR SOFIA WAS ADVANCED AND THE COIL WAS TAKEN OUT WITH THE MICROCATHETER AS A UNIT. THE ENTIRE COIL WAS REMOVED. NEW MICROCATHETER WAS USED TO RE-ACCESS THE ANEURYSM. THE SECOND COIL, A UNIFORM 7MM X 13.9 CM (FCX100713, 31098464) WAS ADVANCED INTO THE ANEURYSM WITHOUT ANY ISSUE. ATTEMPTED TO DETACH COIL WITH MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) UNSUCCESSFULLY. THE MANUAL BREAK WAS USED CORRECTLY AND THAT WAS UNSUCCESSFUL AS WELL. THAT COIL WAS REMOVED WITHOUT ANY ISSUES. A MICRUSPHERE XL 7MMX14CM COIL (SSR10071420, 30529251) WAS USED AT THIS POINT WITH THE SAME MICROCATHETER IN PLACE. THAT COIL FRACTURED AS WELL DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197059 ↗
• InjuryJun 12, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT A 53-YEAR-OLD FEMALE PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT A MIDDLE INTERNAL CAROTID ARTERY (ICA) TORTUOSITY ANEURYSM. PER EVENT DESCRIPTION, ¿THE COIL BECAME STUCK IN THE DETACHMENT DEVICE.¿ IT WAS THEN UNSTUCK BUT THEN THE COIL DID NOT DETACHED PROPERLY. IT WAS FURTHER STATED THAT ¿IT SEEMED AS IF THE STRETCH RESISTANT WIRE HELD ON AND STAYED CONNECTED TO THE COILS AFTER ACTUATION OF THE DETACHMENT DEVICE FAILED.¿ ADDITIONAL CLARIFICATION WAS COLLECTED STATING THAT ¿TWO LOOPS OF COIL DEPLOYED IN ANEURYSM¿, THEN A ¿FRED FLOW DIVERTER WAS DEPLOYED, JAILING THE MICROCATHETER (WHICH TOOK ABOUT 30-40 MINUTES), THUS THEN BEING ABLE TO FULLY DEPLOY THE COIL INTO THE ANEURYSM. IT WAS MENTIONED THAT AT THIS POINT, ¿COIL DETACHMENT WAS ATTEMPTED WITH DETACHER¿ AND THAT BECAUSE ¿PROXIMAL HYPOTUBE WAS STUCK IN DETACHER¿ THIS HAS BEEN PULLED FORM THE DETACHER. ¿A MANUAL BREAK WAS ATTEMPTED AND PULLED, AND THE INNER PULL WIRE BROKE¿. COIL DETACHMENT WAS ATTEMPTED UNSUCCESSFULLY WITH KELLY FORCEPS. BECAUSE COIL WAS STILL ATTACHED, THE COIL WAS PULLED OUT, PUSHED BACK IN FOR 3-TIMES AND EVENTUALLY IT DETACHED IN THE ANEURYSM. THE PROCEDURE WAS FIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105886 ↗