CEREPAK UNIFORM FCX181017Recalls & reported problems
Cerenovus, Inc. · CEREPAK UNIFORM XL Detachable Coil Delivery System Length - 190 cm Coil Diameter - 10 mm Coil Length - 17.1 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704084334), received between Apr 29, 2024 and Apr 29, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (1 report).
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 Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2024Separation Failure; Separation Failure
AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE RIGHT CAROTID TERMINUS, THE PHYSICIAN HAD DETACHMENT ISSUES WITH A UNIFORM XL 10MM X 17.1 CM COIL (FCX181017, 31243967). THE MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) DID NOT BREAK. HE WAS ABLE TO GET IT TO DETACH BY PUSHING THE COIL PUSHER RAPIDLY IN AND OUT. THE NEXT COIL WAS A FREEFORM 9MM X 25 CM (SCR120925, 31173116), THE HANDLE DETACHMENT FAILED, AND HE THEN TRIED THE MANUAL BREAK, THIS ONE DETACHED. THEN A FREEFORM 6MM X 20 CM COIL (SCR120620, 31058141) WAS USED. THE HANDLE FAILED AND SO DID THE MANUAL BREAK. HE TRIED TO MAKE IT DETACH BY PUSHING THE COIL PUSHER IN AND OUT IN HOPES IT WOULD RELEASE. THE PHYSICIAN THEN TRIED TO REMOVE THE COIL, WHILE PULLING IT OUT OF THE ANEURYSM THE COIL DETACHED IN THE ECHELON 10 MICROCATHETER (MC). HE WAS ABLE TO PUSH THE COIL BACK INTO THE ANEURYSM WITH A MICROWIRE. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 16-APR-2024 INDICATING THAT THE UNIFORM XL 10MM X 17.1 CM COIL WAS THE FIRST COIL TO BE USED. THERE WAS NO RESISTANCE WHILE PUSHING THE COILS THROUGH THE MICROCATHETER; THERE WAS NO DIFFICULTY POSITIONING THE MICROCATHETER INTO THE ANEURYSM HOWEVER THERE WAS DIFFICULT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19201395 ↗
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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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