CEREPAK FREEFORM MCR092545Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM Mini Detachable Coil Delivery System Length - 190 cm Coil Diameter -2.5 mm Coil Length - 4.5 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 10886704083030), received between Apr 18, 2024 and Apr 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
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.
MalfunctionApr 18, 2024Failure to Advance; Failure to Advance
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED LEFT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, THE 2.5MM X 4.5CM CEREPAK FREEFORM MINI (MCR092545 / 31201421) FAILED TO ADVANCE MORE THAN 2CM INTO THE CONCOMITANT MICROCATHETER. PRIOR TO THE USE OF THIS COIL, THREE (3) OTHER CEREPAK COILS WERE ADVANCED THROUGH THE SYSTEM AND WERE SUCCESSFULLY DEPLOYED. WHEN THE TECHNOLOGIST FELT RESISTANCE, THE COIL WAS RETRACTED BACK INTO THE INTRODUCER SHEATH AND THEN ADVANCED AGAIN WITH NO SUCCESS. THE COIL WAS REMOVED, AND THE SYSTEM CHECKED FOR SIGNS THAT WOULD HAVE CAUSED THE RESISTANCE. NOTHING WAS NOTED BY THE PHYSICIAN. THE COIL WAS INSPECTED FOR ANY DAMAGE BEFORE BEING RE-SHEATHED AND ATTEMPTED TO USE AGAIN. NO DAMAGE WAS NOTED, AND THE COIL MET THE SAME RESISTANCE WHEN IT WAS ADVANCED FOR THE THIRD TIME. THE 2.5MM X 4.5CM CEREPAK FREEFORM MINI WAS REMOVED AND A 2MM X 6CM CEREPAK FREEFORM MINI WERE USED WITH NO ISSUES. THE PROCEDURE CONTINUED WITH THREE (3) MORE SUCCESSFULLY DEPLOYED COILS THROUGH THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 11-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19137726 ↗
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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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