MICRUSFRAME MFR100253Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704077770), received between Apr 20, 2017 and Nov 6, 2019 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, A 2.5MM X 3.3CM MICRUSFRAME10 COIL (MFR100253, UNKNOWN LOT) CAME BACK TO THE UNSPECIFIED MICROCATHETER AFTER IT WAS DETACHED. ONE MINUTE LATER, THE PHYSICIAN PUSHED THE COIL BACK INSIDE OF THE ANEURYSM. NO PATIENT COMPLICATIONS OR SURGICAL DELAY OCCURRED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: No Code Available

  MAUDE report 9287116 ↗
• InjurySep 4, 2019Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ANEURYSM COILING PROCEDURE, THE 2.5MM X 3.3CM MICRUSFRAME10 (MFR100253/L10193) COIL DID NOT DETACH WHEN THE DETACHMENT PROCESS WAS INITIATED. THE SURGEON HAD TO PRESS A DOZEN TIMES FOR THE COIL TO DETACH AND ¿THIS RESULTED IN A MOVEMENT OF THE CAGE CREATED DURING DEPLOYMENT¿. A CLOT FORMED AT THE NECK OF THE ANEURYSM WHICH WAS TREATED WITH ANTI-PLATELET AGGREGATION THERAPY AND SIX WEEKS OF ASPIRIN. IT WAS REPORTED THAT THE SURGERY WAS NOT DELAYED DUE TO THE EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DEVICE FRAGMENTS WERE GENERATED. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: Thrombosis

  MAUDE report 8961824 ↗
• MalfunctionJul 9, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A CEREBRAL EMBOLIZATION TO THE LEFT ANTERIOR COMMUNICATING ARTERY, A 2.5MM X 3.3CM MICRUSFRAME10 COIL (MFR100253, L14834), DID NOT ADVANCE THROUGH THE PROWLER 14 MICROCATHETER (MC) DURING DELIVERY. THE USER REMOVED BOTH THE COIL AND THE MICROCATHETER AND USED NEW PROWLER AND COIL. AFTER THE CHANGE OF THE DEVICES, THE USER WAS ABLE TO CONTINUE WITH THE EMBOLIZATION WITH NO PROBLEM. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS A 20 MINUTES PROCEDURAL DELAY DUE TO THE EVENT. AFTER INSPECTION OF THE MICROCATHETER, IT LOOKS LIKE THE DISTAL PORTION WAS KINKED. NO EVIDENCE OF WHEN IF HAPPENED AND IF IT IS THE CAUSE OF THIS SITUATION. THE DEVICES WERE VISUALLY INSPECTED FOR DAMAGE PRIOR TO USE. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. ADEQUATE FLUSH BEEN MAINTAINED THROUGH THE DEVICES. THE DEVICES DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. NO EXCESSIVE FORCE BEEN APPLIED TO THE DEVICES. THE RHV IS NOT A PROBLEM, IT WASN´T TOO TIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8773244 ↗
• MalfunctionJul 2, 2019Separation Failure; Separation Failure

  AS REPORTED BY HEALTHCARE PROFESSIONAL, A GALAXY G3 4MM X 12CM COIL (GLY120412, L12634), A MICRUSFRAME10 3.5MM X 6.6CM COIL (MFR100356, LOT UNKNOWN) AND AMICRUSFRAME10 2.5MM X 3.3CM COIL (MFR100253, L10193) COIL WOULD NOT DETACH ONCE DEPLOYED INTO THE ANEURYSM. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENTS. ANOTHER COIL WAS ADVANCED AND DEPLOYED INTO ANEURYSM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8754772 ↗
• MalfunctionDec 21, 2018Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RUPTURED PERICALLOSAL ARTERY ANEURYSM, A 2.5MM X 3.3CM MICRUSFRAME 10 (MFR100253/L10129) THERMO-MECHANICAL COIL WOULD NOT ADVANCE THROUGH THE ECHELON-10 (MEDTRONIC) MICROCATHETER. THE ISSUE REQUIRED THAT BOTH THE COIL AND MICROCATHETER BE REMOVED AS A UNIT, RESULTING IN LOSS OF CEREBRAL TARGET POSITION. THE COIL AND MICROCATHETER WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THREE OTHER COILS WERE USED AND ALL FUNCTIONED APPROPRIATELY. NO VISIBLE PRODUCT DAMAGE WAS NOTED UPON REMOVAL. THE PRODUCT WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT PRODUCT WILL BE RETURNED FOR EVALUATION. THE CONCOMITANT MICROCATHETER IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189777 ↗
• MalfunctionApr 20, 2017Difficult To Position; Difficult To Position

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING TREATMENT OF A SMALL 3.8 X 3.6MM MIDDLE CEREBRAL ARTERY ANEURYSM A MICRUSFRAME (MFR100253/S11567) COULD NOT BE RE-SHEATHED AND A SECOND MICRUSFRAME (SAME CATALOG AND LOT) WAS DIFFICULT TO POSITION IN THE ANEURYSM. WHILE ATTEMPTING TO ACCESS THE ANEURYSM WITH THE FIRST COIL, THE SL 10 MICROCATHETER DID NOT HOLD ITS POSITION. THE COIL COULD NOT BE RE-SHEATHED AND WAS REMOVED FROM USE. THE COIL DID NOT APPEAR DAMAGED (I.E. KINKED, STRETCHED, SEPARATED, DETACHED), AND A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. NEXT, A PROWLER LPES WAS PLACED AND THE SECOND MICRUSFRAME WAS ADVANCED; HOWEVER, THE COIL DID NOT TAKE A PROPER SHAPE AND THE PHYSICIAN KEPT TRYING TO PUSH THE DEVICE, AND IT PROTRUDED INTO THE PARENT VESSEL. IT WAS REPORTED THAT IT ONLY PROTRUDED INTO THE VESSEL FOR A SECOND AND THEN WAS RE-POSITIONED. THE COIL WOULD NOT OPPOSE TO THE WALL OR OPEN PROPERLY. THE PHYSICIAN EXCHANGED THE COIL FOR A COMPETITOR¿S COIL AND COMPLETED THE PROCEDURE BY SUCCESSFULLY PLACING 5 COILS OF VARYING SIZES USING THE SAME PROWLER LPES MICROCATHETER. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED 30 MINUTES DUE TO THE TWO EVEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6507325 ↗