CEREPAK FREEFORM MCR092535Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM Mini Detachable Coil Delivery System Length - 190 cm Coil Diameter - 2.5 mm Coil Length - 3.5 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 10886704083023), received between Aug 1, 2025 and Aug 1, 2025 — 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.
MalfunctionAug 1, 2025Separation Failure; Separation Failure
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.5MM X 3.5CM CEREPAK FREEFORM MINI (MCR092535 / 31212048) WAS POSITIONED AND THERE WERE TWO ATTEMPTS TO DETACH IT WITH THE DETACHMENT HANDLE (MDH1 / 102109430) AND ONCE VIA MANUAL BREAK. THE COIL FAILED TO DETACH. THE PROCEDURE WAS REPORTEDLY DELAYED BY 15 MINUTES, BUT IT WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 31-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING A 3.7MM X 3MM X 3MM UNRUPTURED ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY. WHEN THE COIL WAS REMOVED, IT WAS NOT STRETCHED; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO EVIDENCE OF BLOOD FLOW INTERRUPTION AS A RESULT OF THE REPORTED ISSUE. THE CONCOMITANT MICROCATHETER WAS A 150CM X 50CM PROWLER 14 MICROCATHETER (606151FX). THE PROCEDURE WAS COMPLETED WITH 3MM X 6CM CEREPAK FREEFORM XTRASOFT (XCR120306) USING THE SAME 150CM X 50CM PROWLER 14 MICROCATHETER AND THE SAME DETACHMENT HANDLE (THE LOT NUMBER PROVIDED WAS 102109430). THE INFORMATION INDICATED THAT THE PHYSICIAN DID CONSIDER THE 15-MINUTE PROCEDURE EXTENSION TO BE SIGNIFICAN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22688264 ↗
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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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