MICRUSFRAME MFR181118Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704078067), received between Aug 12, 2020 and Jun 14, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2023Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 60-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING (CURRENT SMOKER) UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION BRANCH ANEURYSM WITH A HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.4MM, DOME 10.5MM, MAXIMUM ANEURYSM DIAMETER 10.5MM, NECK SIZE 4.9MM, AND DOME-TO-NECK RATIO OF 2.1MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: AN 11MM X 18.9CM MICRUSFRAME 18 (MFR181118 / 30422246), A 5MM X 9.7CM MICRUSFRAME 10 (MFR100509 / 30537019), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / 30379819), A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30624675), AND A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30789543) VIA AN SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE PRINCIPAL INVESTIGATOR (PI), THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE; THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IMMEDIATE POST-PROCEDURE MODIFIED RAYM

  Patient problems: Aneurysm

  MAUDE report 17131995 ↗
• MalfunctionAug 12, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, THE DELIVERY SYSTEM OF A 11MM X 18.9CM MICRUSFRAME18 COIL (MFR181118, L13717) AND A 12MM X 20.7CM MICRUSFRAME18 COIL (MFR181220, L11577) ARE CAUSING SOME CONCERNS, THE COILS DO NOT FILL THE ANEURYSM AS WELL AS THE USER WAS HOPING. IT IS DIFFICULT TO POSITION THEM. THEY ARE EITHER PROTRUDING INTO A VESSEL OR ARE DIFFICULT TO BE FULLY ADVANCED. THE USER REPORTED THAT SOMETIMES THEY CANNOT ADVANCE A COIL FULLY AND IT¿S NOT DUE TO SIZING, PERHAPS IT IS INDEED DUE TO THE DELIVERY SYSTEM. THE CATHETER KICK BACK IS VERY CONCERNING. THE SYSTEMS, ESPECIALLY THE DELIVERY WIRE FEELS VERY STIFF. IT¿S REQUIRING SOME MANIPULATION. DEPLOYMENT OF COILS TAKES TOO LONG, AS THEY ARE NOT EASY TO HANDLE, WHICH PRESENTS A RISK OF CLOT FORMING. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395636 ↗