CEREPAK FREEFORM SCR121030Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM Detachable Coil Delivery System Length - 190 cm Coil Diameter - 10 mm Coil Length - 30 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 10886704083245), received between Mar 27, 2025 and Mar 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionMar 27, 2025Break; Break
AS REPORTED BY THE FIELD, A FREEFORM XSFT 4MM X 10 CM COIL (XCR120410, 31107820) AND A FREEFORM 10MM X 30 CM COIL (SCR121030, 31177734) WERE ¿DEFECTIVE". ADDITIONAL EVENT INFORMATION RECEIVED ON 13-FEB-2025 INDICATED THAT THE COIL EMBOLIZATION WAS TO A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (BIFURCATION). THERE WAS NO DELAY IN CARE. A 6FR ENVOY DA 95CM, LPES 45, AGILITY SOFT, SHORT SHEATH WERE USED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF BOTH DEVICES RECEIVED, THE EMBOLIC COIL FAILED TO DETACH, WAS FOUND KINK/BENT AND UNRAVELED/STRETCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21708304 ↗
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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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