CEREPAK UNIFORM FCX180714Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704084488), received between Dec 14, 2023 and May 28, 2024 — 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 28, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WHERE THE PHYSICIAN ACCESSED A PREVIOUSLY TREATED, RECANALIZED ANEURYSM WITH AN SL-10® MICROCATHETER (STRYKER). THE PHYSICIAN THEN INSERTED THE COMPLAINT COIL, A 7MM X 14.3CM CEREPAK UNIFORM XL (FCX180714 / 31173115). IT WAS REPORTED THAT ¿FELLOW WENT SLIGHTLY PASSED THE INVERTED T AND WENT TO USE MANUAL BREAK BEFORE BEING TOLD TO PULL BACK A LITTLE. WHEN HE REMOVED THE DELIVERY SYSTEM, THE COIL WAS STILL ATTACHED. [THE] PULL WIRE WAS BROKEN AT THE MANUAL BREAK SITE.¿ AN ATTEMPT TO PULL THE PULL WIRE WITH A HEMOSTAT WAS MADE, BUT ¿UNABLE TO GRASP.¿ THE COIL AND DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS NOT DELAYED, IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 28-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE INTENDED PROCEDURE WAS COILING OF THE PREVIOUSLY TREATED RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. THE ANEURYSM WAS PREVIOUSLY TREATED IN FEBRUARY 2024 (EXACT DATE WAS NOT PROVIDED) AT THE SAME HOSPITAL BY THE SAME PHYSICIAN. THE INFORMATION INDICATED THAT WHEN THE 7MM X 14.3CM CER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19411816 ↗
• MalfunctionDec 14, 2023Separation Failure; Premature Separation; Separation Failure; Premature Separation

  AS REPORTED BY THE FIELD, THIS WAS A VERY TORTUOUS PIPELINE/COILING CASE OF THE LEFT DISTAL INTERNAL CAROTID ARTERY (ICA) OVER A 9MM IN SIZE, NECK MEASURING ALMOST 8MM. A PIPELINE EMBOLIZATION DEVICE WAS DEPLOYED. A HEADWAY DUO 156CM MICROCATHETERWAS JAILED INTO THE ANEURYSM PRIOR TO THE DEPLOYMENT OF THE PIPELINE. THE FIRST OF THE UNIFORM XL 7MM X 14.3 CM COIL ((B)(6)) WAS ADVANCED THROUGH THE MICROCATHETER (MC) WITH MINIMAL RESISTANCE AROUND THE SECOND MANUAL BREAK MARKER. THE COIL WAS INSERTED INTO THE ANEURYSM WITHOUT DIFFICULTY. THE MANUAL BREAK TECHNIQUE WAS ATTEMPTED WITHOUT SUCCESS. AS THE DOCTOR ATTEMPTED TO THEN PULL THE COIL OUT OF THE ANEURYSM, THE COIL SEEMED TO PREMATURELY DETACH IN THE MICROCATHETER. HE WAS ABLE TO PUSH THE COIL BACK INTO THE ANEURYSM. THE REST OF THE CASE WAS COILED WITH THE DP2-3 CASHMEERE COILS WITHOUT ANY ISSUE. NO NEGATIVE PATIENT OUTCOME AND MINIMAL DELAY OF TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327626 ↗