CEREPAK UNIFORM FCX100356Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704083993), received between Oct 26, 2023 and May 23, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION TO AN ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM WITH HIGH TORTUOSITY WITH BILATERAL ACCESS. DIFFICULTY IN ACQUIRING ACCESS IN BOTH FEMORAL ARTERIES. 8 FR SETUP WITH CEREBASE AND SOFIA IN THE LEFT FEMORAL AND 6 FR SETUP WITH BENCHMARK IN THE RIGHT FEMORAL. A HEADWAY DUO 156 CM MICROCATHETER WAS NAVIGATED ACROSS THE ACOMM TO DEPLOY AN ATLAS STENT FROM THE LEFT. ANOTHER HEADWAY DUO 156 CM WAS JAILED INTO THE ANEURYSM FROM THE RIGHT. THE ATLAS STENT WAS DEPLOYED. AN UNIFORM 3.5MM X 6.6 CM COIL (FCX100356, 31098459) WAS SUCCESSFUL USED TO FRAME THIS ANEURYSM BUT DID NOT DEPLOY WITH THE MECHANICAL HANDLER (UNKNOW PRODUCT CODE, LOT) OR MANUAL BREAK. THAT COIL WAS REMOVED WITHOUT ISSUE. ANOTHER UNIFORM 3.5MM X 6.6 CM COIL (FCX100356, 31098459) WAS SUCCESSFUL USED TO FRAME THIS ANEURYSM BUT ALSO DID NOT DETACH USING THE HANDLE OR MANUAL BREAK. THAT COIL WAS REMOVED WITHOUT ISSUE. NO SIGNIFICANT DELAY OR NEGATIVE IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382068 ↗
• MalfunctionMay 23, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION TO AN ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM WITH HIGH TORTUOSITY WITH BILATERAL ACCESS. DIFFICULTY IN ACQUIRING ACCESS IN BOTH FEMORAL ARTERIES. 8 FR SETUP WITH CEREBASE AND SOFIA IN THE LEFT FEMORAL AND 6 FR SETUP WITH BENCHMARK IN THE RIGHT FEMORAL. A HEADWAY DUO 156 CM MICROCATHETER WAS NAVIGATED ACROSS THE ACOMM TO DEPLOY AN ATLAS STENT FROM THE LEFT. ANOTHER HEADWAY DUO 156 CM WAS JAILED INTO THE ANEURYSM FROM THE RIGHT. THE ATLAS STENT WAS DEPLOYED. AN UNIFORM 3.5MM X 6.6 CM COIL (FCX100356, 31098459) WAS SUCCESSFUL USED TO FRAME THIS ANEURYSM BUT DID NOT DEPLOY WITH THE HANDLE OR MANUAL BREAK. THAT COIL WAS REMOVED WITHOUT ISSUE. ANOTHER UNIFORM 3.5MM X 6.6 CM COIL (FCX100356, 31098459) WAS SUCCESSFUL USED TO FRAME THIS ANEURYSM BUT ALSO DID NOT DETACH USING THE HANDLE OR MANUAL BREAK. THAT COIL WAS REMOVED WITHOUT ISSUE. NO SIGNIFICANT DELAY OR NEGATIVE IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381947 ↗
• MalfunctionFeb 13, 2024Activation Problem; Activation Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE POSTERIOR INFERIOR CEREBELLAR ARTERY, MANUAL BREAK WAS ATTEMPTED WITH A TWO UNIFORM 3.5MM X 6.6 CM COILS ((B)(4)), HOWEVER IT DID NOT DETACH. PULLED ANOTHER 2 CM, PROXIMAL END OF DELIVERY WIRE BROKE OFF. THERE WAS A PROCEDURAL DELAY OF 15 MINUTES DUE TO THE REPORTED EVENT. UTILIZED SPECTRA COIL LINE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-FEB-2025 INDICATED THAT A SL10 150CM MICROCATHETER WAS USED. NO COILS HAD BEEN PREVIOUSLY IMPLANTED. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. NO ATTEMPTS WERE MADE WITH THE DETACHMENT HANDLER. THE VESSEL WAS TORTUOUS WITH 90-DEGREE BENDS AND 360 LOOP. THE 15-MINUTE PROCEDURAL DELAY WAS NOT SIGNIFICANT. THE PHYSICIAN WAS MORE CONCERNED ABOUT THE PATIENT SAFETY AND POTENTIALLY HAVING TO RE-ACCESS WITH A NEW MICROCATHETER. CONCERN OF DECREASED INTEGRITY OF THE INNER LUMEN OF THE MICROCATHETER BECOMING COMPROMISED BY FRICTION DUE TO THE UNNECESSARY PASSES OF THE UNDEPLOYED COILS. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-FEB-2024 CLARIFIED THAT THE ¿PU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695229 ↗
• MalfunctionFeb 13, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE POSTERIOR INFERIOR CEREBELLAR ARTERY, MANUAL BREAK WAS ATTEMPTED WITH A TWO UNIFORM 3.5MM X 6.6 CM COILS ((B)(6)), HOWEVER IT DID NOT DETACH. PULLED ANOTHER 2 CM, PROXIMAL END OF DELIVERY WIRE BROKE OFF. THERE WAS A PROCEDURAL DELAY OF 15 MINUTES DUE TO THE REPORTED EVENT. UTILIZED SPECTRA COIL LINE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-FEB-2025 INDICATED THAT A SL10 150CM MICROCATHETER WAS USED. NO COILS HAD BEEN PREVIOUSLY IMPLANTED. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. NO ATTEMPTS WERE MADE WITH THE DETACHMENT HANDLER. THE VESSEL WAS TORTUOUS WITH 90-DEGREE BENDS AND 360 LOOP. THE 15-MINUTE PROCEDURAL DELAY WAS NOT SIGNIFICANT. THE PHYSICIAN WAS MORE CONCERNED ABOUT THE PATIENT SAFETY AND POTENTIALLY HAVING TO RE-ACCESS WITH A NEW MICROCATHETER. CONCERN OF DECREASED INTEGRITY OF THE INNER LUMEN OF THE MICROCATHETER BECOMING COMPROMISED BY FRICTION DUE TO THE UNNECESSARY PASSES OF THE UNDEPLOYED COILS. ADDITIONAL EVENT INFORMATION RECEIVED ON 08-FEB-2024 CLARIFIED THAT THE ¿PU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695228 ↗
• MalfunctionOct 26, 2023Positioning Failure; Stretched; Positioning Problem; Positioning Failure; Stretched; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A RECANALIZATION TO AN ANEURYSM AT THE DISTAL INTERNAL CAROTID ARTERY (ICA), AN OPTIMAX 4.5 X 10 WAS USED AS THE FIRST COIL. THE COIL WAS CONSIDERED TOO BIG AND REMOVED FROM ANEURYSM. THE DECISION TO USE AN UNIFORM COIL 3.5MM X 6.6CM (FCX100356, 31098459) WAS MADE AND OPENED. THE ACCESS TO THE ANEURYSM WAS UNSTABLE AND THE SL-10 MICROCATHETER (MC) THEN MOVED INTO THE PARENT VESSEL AS THE UNIFORM COIL WAS ADVANCED THROUGH THE MICROCATHETER. THE UNIFORM COIL WAS THEN REMOVED AND ATTEMPTED TO BE RESHEATHED THROUGH THE HUB INTO THE INTRODUCER SHEATH OF THE COIL. THE TAPERED END OF THE SHEATH WAS USED CORRECTLY BUT THE COIL BECAME STRETCHED, AND THE COIL WAS ON THE STERILE FIELD. THE MICROCATHETER WAS INTACT AND THE COIL WAS NOT IN THE PATIENT¿S BODY. NO IMPACT TO PATIENT AND MINIMAL TIME DELAY DUE TO THIS RESHEATHING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014327 ↗