CEREPAK FREEFORM SCR120308Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM Detachable Coil Delivery System Length - 190 cm Coil Diameter - 3 mm Coil Length - 8 cm · Class 2 · Implant
All models of CEREPAK FREEFORM (60)
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 10886704083108), received between Sep 3, 2024 and Sep 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Problem” (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
- Activation Problem1
- 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.
MalfunctionSep 3, 2024Separation Failure; Activation Problem; Separation Failure; Activation Problem
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, AFTER ¿JAILING¿ THE SL-10® MICROCATHETER (STRYKER) IN THE ANEURYSM WITH A NEUROFORM ATLAS® STENT SYSTEM (STRYKER), COIL EMBOLIZATION WAS COMMENCED. THE FIRST TWO CEREPAK FREEFORM COILS, A 5MM X 15CM CEREPAK FREEFORM AND A 4MM X 10CM CEREPAK FREEFORM, WERE SUCCESSFULLY DEPLOYED VIA MANUAL BREAK. A THIRD CEREPAK COIL, 3MM X 8CM CEREPAK FREEFORM (SCR120308 / 31149188) WAS POSITIONED AFTER THE FIRST TWO COILS. AFTER SNAPPING THE DETACHMENT ZONE AT THE ENGINEERED FRACTURE POINT AND WIRE WAS EXPOSED, THE PHYSICIAN REPORTED FEELING A LOT OF TENSION COMPARED TO THE FIRST TWO COILS. THE PHYSICIAN WAS ADVISED TO STOP PULLING AND THE SYSTEM WAS ASSESSED TO REDUCE ANY PROXIMAL FRICTION OUTSIDE AND TO REDUCE ANY POSSIBLE FORWARD TENSION ON THE INSIDE, IN THE PATIENT¿S ANATOMY. DETACHMENT WAS RE-ATTEMPTED WITH THE PULL WIRE BREAKING. NO PULL WIRE WAS LEFT TO TRANSLATE AND THE 3MM X 8CM CEREPAK FREEFORM COIL WAS REMOVED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING STRYKER 360 COILS. THE PROCEDURE WAS PROLONGED BY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20130793 ↗
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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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