MICRUSFRAME MFR100816Recalls & reported problems
Cerenovus, Inc. · MICRUSFRAME S Microcoil 10 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: MICRUSFRAME S 10 Stretch Resistant Coil 8mm (coil diameter) x 16.1cm (coil length) 190cm (working length) · Class 2 · Implant
All models of MICRUSFRAME (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704077893), received between Sep 11, 2022 and Sep 11, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Aneurysm1
- Ischemia Stroke1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 54-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION AND BEING A CURRENT SMOKER, UNDERWENT COIL EMBOLIZATION OF A MIDLINE RUPTURED ANEURYSM IN THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AND A HUNT & HESS GRADE OF 3 (DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT) ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 8MM, DOME 6MM, MAXIMUM ANEURYSM DIAMETER 8MM, NECK SIZE 5MM, AND THE DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 2.7MM. COIL EMBOLIZATION WAS PERFORMED AND CERENOVUS STUDY COILS WERE ADVANCED BEYOND THE DISTAL TIP OF THE MICROCATHETER, BUT THE SPECIFIC DEVICE INFORMATION WAS NOT ENTERED INTO THE CASE REPORT FORM (CRF). THE COIL WAS IMPLANTED VIA ECHELON¿ 10 MICROCATHETER (MEDTRONIC). A BALLOON CATHETER (UNSPECIFIED BRAND) WAS ALSO USED. THE IMMEDIATE POST-PROCEDURE IMAGING INFORMATION WAS NOT ENTERED INTO THE CRF. THE PATIENT DID NOT EXPERIENCE AN INTRA-OPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2021. THE MODIFIED RANKIN SCALE SCORE AND THE HUNT & HESS GRADE WERE NOT ENTERED INT
Patient problems: Aneurysm; Ischemia Stroke
MAUDE report 15398181 ↗
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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
- 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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