CEREPAK FREEFORM SCR120715Recalls & reported problems
Cerenovus, Inc. · CEREPAK FREEFORM Detachable Coil Delivery System Length - 190 cm Coil Diameter - 7 mm Coil Length - 15 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 10886704083191), received between Jun 17, 2024 and Jun 17, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult 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 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
- Difficult to Advance1
- Material Twisted/Bent1
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 17, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent
IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A FREEFORM 7MM X 15 CM (SCR120715/31058142), A FREEFORM 7MM X 21 CM (SCR120721/31131258), A MECHANICAL DETACHMENT HANDLE (MDH1/97988374), AND A FREEFORM 7MM X 21 CM (SCR120721/31131258), WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN INTRACRANIAL ANEURYSM AT THE M1 BIFURCATION OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED FAILURE TO DETACH FROM THE MECHANICAL DETACHMENT HANDLE. FOR THE FIRST COIL USED (COIL 7MM X 15CM FREEFORM), THE USER REPORTED A KINK/BEND IN THE CEREPAK DELIVERY TUBE AND COIL POSITIONING / STABILITY DIFFICULTY WITH LOSS OF CEREBRAL TARGET. FOR THE SECOND COIL USED (COIL 7MM X 21CM), THE USER REPORTED A KINK/BEND -IN PATIENT TO THE CEREPAK DELIVERY TUBE AND COIL - FAILURE TO DETACH. FOR THE THIRD COIL USED (SECOND COIL 7MM X 21CM), THE USER REPORTED FAILURE TO DETACH AND PREMATURE DETACHMENT-IN MICROCATHETER DURING REMOVAL. DURING THE REMOVAL OF THE LAST COIL, THE COIL DETACHED/ BROKE AND FLOATED INTO THE INTERNAL CAROTID ARTERY (ICA) TERMINUS. SEVERAL ATTEMPTS TO RETRIEVE THE COIL PROVED TO BE UNSUCCESSFUL. AS A RESULT, THE PHYSICIAN USED AN ATLAS STENT (STRYKER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19547284 ↗
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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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