MICRUSFRAME MFR140406Recalls & reported problems
Cerenovus, Inc. · MICRUSFRAME C Microcoil 14 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: MICRUSFRAME C 14 Stretch Resistant Coil 4mm (coil diameter) x 6cm (coil length) 190cm (working length) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704077978), received between Oct 2, 2019 and Oct 2, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2019Material Twisted/Bent; Material Twisted/Bent
AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE TAB TO UNLOCK A 4MM X 6CM MICRUSFRAME14 COIL (MFR140406, S13486) BROKE. A HEMOSTAT WAS USED TO MANUALLY PULL THE TAB FROM THE GREEN UNLOCKING TOOL. THE COIL WAS NOT USED IN CASE BECAUSE OF THAT REASON. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. NO FURTHER INFORMATION IS AVAILABLE. BASED ON THE FINDINGS OF THE DEVICE INVESTIGATION, THE EMBOLIC COIL WAS NOTED TO BEING KINKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9146292 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
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- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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