MICRUSFRAME MFR100202Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704077787), received between Sep 5, 2019 and Apr 19, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2023, THE COMPLAINT COIL, A 2MM X 2.5CM MICRUSFRAME 10 (MFR100202) FROM THE REPORTED LOT # OF 30682230, WAS SUSPECTED TO HAVE A PROBLEM WITH THE ELECTRICAL DISCONNECTION, LEAVING THE METAL FILAMENT BLOCKING THE MICROCATHETER. ON 12-APR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE MIDDLE CEREBRAL ARTERY (MCA). THE REPORTED FILAMENT WAS REPORTED TO BE PART OF THE EMBOLIC COIL; THE INFORMATION ALSO INDICATED THAT THE REPORTED FILAMENT WAS ALSO PART OF THE DELIVERY WIRE COIL. THE EMBOLIC COIL WAS REPORTED TO BE IMPLANTED IN THE PATIENT. THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) WAS REMOVED ¿BECAUSE A COIL IS STUCK IN MICROCATHETER.¿ THE WHOLE SYSTEM WAS REMOVED; A NEW MICROCATHETER AND COIL WERE USED. THERE WAS NO PATIENT ADVERSE EVENT OR HARM. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 12-APR-2023, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773448 ↗
• MalfunctionMay 20, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MM X 2.5CM MICRUSFRAME10 COIL (MFR100202, L16704) WAS BEING USED AS THE FIRST COIL. WHEN THE PHYSICIAN TRIED TO DETACH THE COILS, THE BEEPING SOUND WAS NORMAL BUT DURING RETRIEVING DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEMS. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10074811 ↗
• MalfunctionSep 5, 2019Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE PHYSICIAN DID NOT LIKE THE SHAPE OF A 2MM X 2.5CM MICRUSFRAME10 (MFR100202, L15539) COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RE-SHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8966070 ↗