CEREPAK FREEFORM MCR091015Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM Mini Detachable Coil Delivery System Length - 190 cm Coil Diameter - 1 mm Coil Length - 1.5 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 10886704082903), received between Jun 27, 2023 and Jun 27, 2023 — 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.
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.
MalfunctionJun 27, 2023Separation Failure; Separation Failure
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM TO THE MIDDLE MENINGEAL ARTERY, A FREEFORM MINI 1MM X 1.5CM COIL (MCR091015, 31045734) FAILED TO DETACH. NO PREVIOUS COILS HAD BEEN PREVIOUSLY IMPLANTED. THERE HAD NOT BEEN ANY RESISTANCE DURING ADVANCEMENT OF THE DEVICE THROUGH THE SL10 STRYKER MICROCATHETER (MC) OR POSITIONING DIFFICULTY IN THE ANEURYSM. THERE HAD BEEN THREE ATTEMPTS MADE USING THE DETACHMENT HANDLE PRIOR TO MANUAL DETACHMENT. THERE WAS NO DAMAGE TO THE EMBOLIC COIL OR ANY DEVICE COMPONENT. THERE WAS NO VESSEL ACUTE BENDS. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS ABOUT A 20-MINUTE PROCEDURAL DELAY, WE HAD TO BRING IN THE BALT COIL CART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17210326 ↗
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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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