CEREPAK UNIFORM FCX181846Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704084440), received between Dec 12, 2023 and Dec 12, 2023 — 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.

• MalfunctionDec 12, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PIPELINE / COIL EMBOLIZATION CASE IN TARGETING A RIGHT DISTAL INTERNAL CAROTID ARTERY (ICA) ANEURYSM OVER 2CM IN SIZE WITH A NECK MEASURED AT ALMOST 20MM IN A VERY TORTUOUS VASCULATURE, AFTER MANY ATTEMPTS WITH MULTIPLE WIRES AND CATHETERS, ACCESS WAS OBTAINED INTO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) AND A 5MM X 35MM PIPELINE EMBOLIZATION DEVICE (PED) (MEDTRONIC) WAS DEPLOYED. A HEADWAY® DUO 156 MICROCATHETER (MICROVENTION) WAS JAILED INTO THE ANEURYSM PRIOR TO THE DEPLOYMENT OF THE PED. THE FIRST 18MM X 46CM CEREPAK UNIFORM XL COIL (FCX181846 / 31168338) WAS ADVANCED THROUGH THE MICROCATHETER MINIMAL RESISTANCE AROUND THE SECOND MANUAL BREAK MARKER. THE COIL WAS INSERTED INTO THE ANEURYSM WITHOUT DIFFICULT. THE MANUAL BREAK TECHNIQUE WAS ATTEMPTED WITHOUT SUCCESS. THE WIRE HAD FRACTURED AND THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE WITH A FORCEPS; THE PHYSICIAN ALSO ATTEMPT TO RETRACT THE EXPOSE WIRE WITHOUT SUCCESS. THE COIL WAS THEN REMOVED WITHOUT ISSUE AND WAS FOUND INTACT IN THE FIELD. A SECOND 18MM X 46CM CEREPAK UNIFORM XL COIL FROM THE SAME LOT (31168338) WAS ADVANCED WITHOUT ANY ISSUE. A CEREPAKTM DETACHER (MDH1 / 102

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315587 ↗
• MalfunctionDec 12, 2023Material Separation; Separation Failure; Difficult to Advance; Material Separation; Separation Failure; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PIPELINE / COIL EMBOLIZATION CASE IN TARGETING A RIGHT DISTAL INTERNAL CAROTID ARTERY (ICA) ANEURYSM OVER 2CM IN SIZE WITH A NECK MEASURED AT ALMOST 20MM IN A VERY TORTUOUS VASCULATURE, AFTER MANY ATTEMPTS WITH MULTIPLE WIRES AND CATHETERS, ACCESS WAS OBTAINED INTO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) AND A 5MM X 35MM PIPELINE EMBOLIZATION DEVICE (PED) (MEDTRONIC) WAS DEPLOYED. A HEADWAY® DUO 156 MICROCATHETER (MICROVENTION) WAS JAILED INTO THE ANEURYSM PRIOR TO THE DEPLOYMENT OF THE PED. THE FIRST 18MM X 46CM CEREPAK UNIFORM XL COIL (FCX181846 / 31168338) WAS ADVANCED THROUGH THE MICROCATHETER MINIMAL RESISTANCE AROUND THE SECOND MANUAL BREAK MARKER. THE COIL WAS INSERTED INTO THE ANEURYSM WITHOUT DIFFICULT. THE MANUAL BREAK TECHNIQUE WAS ATTEMPTED WITHOUT SUCCESS. THE WIRE HAD FRACTURED AND THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE WITH A FORCEPS; THE PHYSICIAN ALSO ATTEMPT TO RETRACT THE EXPOSE WIRE WITHOUT SUCCESS. THE COIL WAS THEN REMOVED WITHOUT ISSUE AND WAS FOUND INTACT IN THE FIELD. A SECOND 18MM X 46CM CEREPAK UNIFORM XL COIL FROM THE SAME LOT (31168338) WAS ADVANCED WITHOUT ANY ISSUE. A CEREPAKTM DETACHER (MDH1 / 102

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315585 ↗