CEREPAK UNIFORM FCX100517Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704084020), received between Apr 24, 2024 and Aug 12, 2025 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Material Separation; Separation Failure; Material Separation; Separation Failure

  IT WAS REPORTED, VIA HEALTHCARE PROFESSIONAL, THAT A UNIFORM 5MM X 17 CM (FCX100517/ 31127138) AND A FREEFORM XSFT 3.5MM X 5 CM (XCR123505/ LOT # UNKNOWN) WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED EMBOLIC COIL-FAILURE TO DETACH AND CEREPAK DELIVERY TUBE - SEPARATION DURING USE. WHILE ATTEMPTING TO PLACE THE UNIFORM 5MM X 17 CM EMBOLIC COIL, THE PULL WIRE ¿SNAPPED¿ WHEN PULLING BACK ON THE HYPOTUBE DURING MECHANICAL BREAK DETACHMENT, AND THE COIL WOULD NOT DETACH. THE COIL WAS SUBSEQUENTLY REMOVED, AND A UNIFORM 5X10 COIL WAS USED INSTEAD, WHICH SUCCESSFULLY DETACHED, HOWEVER, ¿THE PROCESS WAS NOT SMOOTH.¿ A THIRD COIL, THE FREEFORM XSFT 3.5MM X 5 CM, WAS THEN ATTEMPTED WITHIN THE ANEURYSM, BUT DURING A PRE-DETACHMENT RUN, THE PHYSICIAN SUSPECTED A RUPTURE. HE PROCEEDED TO DETACH THE COIL, HOWEVER, IT WOULD NOT DETACH, AND THE PULL WIRE SNAPPED WHEN PERFORMING MECHANICAL BREAK. THE COIL WAS REMOVED, AND THE SUSPECTED RUPTURE WAS MANAGED WITH BALLOON ANGIOPLASTY, WHICH WAS SUCCESSFUL. THE PHYSICIAN ASSESSMENT OF EVENTS WAS REPORTED AS SUCH, ¿HE¿S NOT SURE IF IT EVEN WAS A RUPT

  Patient problems: No Clinical Signs, Symptoms or Conditions; Ruptured Aneurysm

  MAUDE report 22786136 ↗
• MalfunctionNov 4, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED BASILAR TIP ANEURYSM, THE PHYSICIAN EXPERIENCED DETACHMENT ISSUES WITH THREE CEREPAK COILS: A 5MM X 17CM CEREPAK UNIFORM (FCX100517 / 31127138), THIS WAS THE 7TH COIL USED IN THE PROCEDURE, A 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167), THIS WAS THE 15TH COIL USED IN THE PROCEDURE, AND THE 16TH COIL, ANOTHER 2.5MM X 5CM CEREPAK FREEFORM XTRASOFT (XCR122505 / 31077167). IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PLACE THE COILS THROUGH AN SL-10® MICROCATHETER (STRYKER) MICROCATHETER. THEN ONCE THE COILS WERE ADVANCED INTO POSITION, THE PHYSICIAN HOOKED UP TO THE DETACHMENT HANDLE (MDH1 / LOT# UNKNOWN) AND ATTEMPT TO DETACH. FOR EACH OF THE THREE COILS, AFTER THE FIRST ATTEMPTED DETACHMENT, THE PHYSICIAN NOTED THAT THE COILS HAD NOT DETACH AND HE REATTACHED THE COILS TO THE DETACHMENT HANDLE AND MADE SECOND UNSUCCESSFUL ATTEMPT TO DETACH THE COILS. IT WAS REPORTED THAT THE COILS WERE REMOVED AND THE PHYSICIAN CONTINUED WITH THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY. ON 24-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604650 ↗
• MalfunctionApr 24, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A UNIFORM 5MM X 17 CM COIL ( FCX100517, 31127138) DID NOT DETACH. WAS SUCCESSFULLY RE-SHEATED AND THERE WAS NO PATIENT IMPACT. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177154 ↗