MICRUSFRAME MFR181220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704078081), received between Aug 20, 2019 and Aug 12, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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.

• 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. IMAGING WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395632 ↗
• MalfunctionAug 20, 2019Product Quality Problem; Malposition of Device; Product Quality Problem; Malposition of Device

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, WHEN THE 12MM X 20.7CM MICRUSFRAME 18 COIL (MFR181220 / L11577) WAS INSIDE THE PATIENT IT WAS NOTED THAT THE MARKER BAND WAS NOT IN THE CORRECT POSITION. THE HEIGHT OF THE PROXIMAL MARKERS NEEDED FOR ORIENTATION UNDER X-RAY DIFFERED FROM THE STANDARD. THE COIL HAD ALREADY EXITED THE MICROCATHETER WHEN FLUOROSCOPY WAS INITIATED, THOUGH IT HAD NOT EXITED VERY FAR FROM THE MICROCATHETER; IT WAS REPORTED THAT THERE IS NO ACCURATE INFORMATION ON HOW FAR THE MICROCATHETER HAD EXITED THE MICROCATHETER WHEN FLUORO WAS INITIATED. THE MOST DISTAL MARKER WAS REPORTED TO BE IN THE CORRECT POSITION. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE MARKER WAS NOT DISLODGED INTO THE PATIENT; IT WAS FURTHER REPORTED THAT THE DEVICE POSITIONING UNIT (DPU) AND THE COIL PUSHER WILL BE RETURNED TO SHOW THE INCORRECT POSITION OF THE MARKER. IT WAS REPORTED THAT THERE WAS SOME ISSUE WITH POSITIONING THE COIL BUT THERE WAS NO ISSUE WITH THE COIL CONFORMING TO THE ANEURYSM WALL; THE COIL WAS IMPLANTED IN THE ANEURYSM AS EXPECTED WITHOUT ANY PATIENT INJURY. THERE WAS NO REPORT OF PROCEDURAL DELAY AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912685 ↗