MICRUSFRAME MFR181343Recalls & reported problems
Cerenovus, Inc. · MICRUSFRAME S Microcoil 18 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: MICRUSFRAME S 18 Stretch Resistant Coil 13mm (coil diameter) x 43cm (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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704078104), received between Jan 18, 2019 and Jan 18, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Positioning Problem1
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.
MalfunctionJan 18, 2019Positioning Problem; Positioning Problem
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM AT THE CELIAC TRUNK WITH THE SIZE OF THE LESION MEASURED AT 13 MM X 11 MM, AFTER A CORONARY STENT WAS IMPLANTED, THE 13 MM X 43 CM MICRUSFRAME 18 COIL (MFR181343 / S12995) WAS CHOSEN AS THE FIRST COIL AND WAS DELIVERED TO THE TARGET LESION. THE COIL WAS REPORTED TO HAVE POOR CONFORMABILITY. THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COIL TO REPOSITION THE MICROCATHETER, BUT THE PHYSICIAN WAS NOT ABLE TO RE-SHEATH THE COIL; THE COIL WAS REMOVED AND REPLACED. IT WAS CONFIRMED THAT THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. ANOTHER 13 MM X 43 CM MICRUSFRAME 18 COIL WAS USED AFTER THE MICROCATHETER WAS REPOSITIONED. FIVE ADDITIONAL COILS WERE IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTEN
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8260972 ↗
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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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