CEREPAK FREEFORM SCR120412Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM Detachable Coil Delivery System Length - 190 cm Coil Diameter - 4 mm Coil Length - 12 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 10886704083139), received between Jan 2, 2024 and Jan 2, 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.
MalfunctionJan 2, 2024Separation Failure; Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN WAS EMBOLIZING A CAROTID-CAVERNOUS FISTULA (CCF) WITH MODERATE TORTUOSITY. THE PHYSICIAN DEPLOYED A TOTAL OF 12 COILS AD THEN USED ONYX¿ 34 LIQUID EMBOLIC AND ONYX¿ 18 LIQUID EMBOLIC (MEDTRONIC). THE FOLLOWING THREE COILS: 5MM X 10CM CEREPAK FREEFORM XSFT (XCR120510 / 31146337), 5MM X 15CM CEREPAK FREEFORM XSFT (XCR120515 / 31173107), AND 4MM X 12CM CEREPAK FREEFORM (SCR120412 / 31140706) DID NOT DETACH UTILIZING THE MANUAL DETACHMENT. IT WAS REPORTED THAT BREAKING OF THE MANUAL BREAK WAS DIFFICULT, BUT ULTIMATELY IT WAS ABLE TO EXPOSE THE PULL WIRE AND PULL BACK THE WIRE TO ATTEMPT TO DETACH THE COIL. THE DIFFICULTY WITH THE BREAKING OF THE MANUAL BREAK AT THE SORTING HAPPENED ON ALL COILS DOCUMENTED IN THIS COMPLAINT. ALL THREE COILS WERE ABLE TO BE REMOVED WITHOUT ANY NEGATIVE PATIENT IMPACT. ONE OF THE COILS REPORTEDLY DETACHED ON THE TABLE AFTER REMOVAL. THE REPORTED ISSUE RESULTED IN MINIMAL DELAY. THERE WAS NO NEGATIVE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18432785 ↗
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
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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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