CEREPAK UNIFORM FCX100509Recalls & reported problems
Cerenovus, Inc. · CEREPAK UNIFORM Detachable Coil Delivery System Length - 190 cm Coil Diameter - 5 mm Coil Length - 9.7 cm · Class 2 · Implant
All models of CEREPAK UNIFORM (58)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704084037), received between Apr 30, 2024 and Mar 12, 2025 — 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Separation Failure2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TO THE INTERNAL CAROTID ARTERY (ICA), A UNIFORM 5MM X 9.7 CM COIL (FCX100509, 31218796), A FREEFORM MINI 2MM X 3CM COIL (MCR092030, 31349399) AND A FREEFORM MINI 2MM X 3CM COIL (MCR092030, 31077163) DID NOT DETACHED WITH MANUAL BREAK METHOD. ADDITIONAL EVENT INFORMATION RECEIVED ON 27-FEB-2025 INDICATED THAT A PROWLER LPES MICROCATHETER WAS USED. SEVEN COILS WERE PREVIOUSLY PLANTED WITH NO ISSUES. THERE HAD BEEN NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE(S) THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE WERE NO ATTEMPTS MADE USING THE DETACHMENT HANDLE. THERE WAS NO COIL DAMAGE. THIS WAS A TORTUOUS VESSEL WITH WIDE NECK DEFECT. THE THREE MINUTES PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT. ALL THREE COILS HAD TO BE RESHEATHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21585109 ↗MalfunctionApr 30, 2024Material Separation; Separation Failure; Material Separation; Separation Failure
DURING A COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY (MCA), A UNIFORM 5MM X 9.7 CM COIL (FCX100509, 31098460) DID NOT DETACH AFTER MULTIPLE ATTEMPTS. THE COIL WAS REMOVED FROM THE ANEURYSM AND SET ASIDE WITHOUT INJURY TO THE PATIENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 29-APR-2024 INDICATED THAT A STRYKER SL-10 MICROCATHETER (MC) WAS USED. SIX COILS WERE PREVIOUSLY IMPLANTED DURING THE PROCEDURE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR POSITIONING DIFFICULTY IN THE ANEURYSM. NO WERE MADE USING THE DETACHMENT HANDLE. PROXIMAL END OF PUSHER TUBE SLIPPED OFF. PULL WIRE BROKE. THE VESSEL WAS MODERATELY TORTUOUS. THE EVENT WAS DELAYED BY 7 MINUTES, NOT CLINICALLY SIGNIFICANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19215727 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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