CEREPAK FREEFORM XCR122525Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM XtraSoft Detachable Coil Delivery System Length - 190 cm Coil Diameter - 2.5 mm Coil Length - 2.5 cm · Class 2 · Implant
All models of CEREPAK FREEFORM (60)
Data updated Oct 16, 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 10886704083740), received between Aug 26, 2024 and Aug 26, 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 16, 2026.
Reports received per month
Recalls naming this device
- Oct 2, 2025Open, 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.
MalfunctionAug 26, 2024Separation Failure; Separation Failure
AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN ANTERIOR COMMUNICATING ARTERY (ACOM) PREVIOUSLY TREATED ANEURYSM,, FIVE FREEFORM COILS WERE PREVIOUSLY DETACHED WITH MANUAL DETACHMENT. HOWEVER, THE SIXTH COIL, A FREEFORM XSFT 2.5MM X 2.5 CM (XCR122525, 31140718) DID NOT DETACH. MANUAL PULL WIRE WAS PULLED SLOWLY JUST LIKE THE PREVIOUS 5 COILS AND NO TORTUOSITY OF CATHETERS OUTSIDE THE BODY. THE COIL WAS REMOVED, AND ANOTHER COIL WAS SUCCESSFULLY PLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 19-AUG-2024 INDICATED THAT A PROWLER LPES 45 MICROCATHETER WAS USED. THERE WAS NO RESISTANCE NOTED AT ALL DURING DELIVERY. NO ATTEMPTS WERE MADE WITH THE DETACHMENT HANDLE, THE PHYSICIAN PREFERENCE IS MANUAL BREAK. THE COIL DOESN'T APPEAR TO HAVE ANY DAMAGE. THE VESSEL WASN'T TORTUOUS AND WAS A STRAIGHT SHOT INTO ANEURYSM OFF PARENT VESSEL. THERE WAS LESS THAN A FIVE MINUTES PROCEDURAL DELAY AS ANOTHER COIL OF THE SAME SIZE WAS SUCCESSFULLY DETACHED. THE PATIENT WAS PREVIOUSLY STENT COILED IN 2016.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20066420 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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