MICRUSFRAME MFR180612Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704078197), received between Feb 8, 2017 and Feb 3, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2025Stretched; Positioning Problem; Stretched; Positioning Problem

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A MICRUSFRAME18 6MM X 12.2CM (MFR180612/ 30751838) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING ARTERY. IT WAS DISCLOSED THAT ¿THE VESSEL LEADING UP TO THE ANEURYSM NECK WAS VERY DYSPLASTIC (ALMOST BALLOON LIKE).¿ DURING THE PROCEDURE, THE USER REPORTED DIFFICULTY POSITIONING THE COIL AND COIL -UNRAVELING/STRETCHED DURING PLACEMENT. THE PHYSICIAN THEN CUT THE PROXIMAL PORTION OF THE MICROCATHETER (EXCELSIOR SL-10 MICROCATHETER; STRYKER) AND REMOVED THE COIL AND THE SEPARATED PORTION OF THE MICROCATHETER BY DEPLOYING A MICRO-SNARE. THE PHYSICIAN THEN DEPLOYED A MICRUSFRAME 10 5MM X 9.7CM SUCCESSFULLY ALONG WITH SUBSEQUENT MICROVENTION COILS TO A SATISFACTORY RESULT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES OCCURRED. NO DEVICE FRAGMENTS WERE GENERATED FROM THE EVENT. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. IT WAS FURTHER NOTED, ¿AFTER THE CASE THE PHYSICIAN NOTED THAT HE DIDN'T FEEL THAT THE COIL WAS AT FAULT FOR THE STRETCHING, AND IT WAS DUE TO ¿OVER-MANIPULATION¿ BY HIM IN TRYING TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293820 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 52-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPOTHYROIDISM UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT MIDDLE CEREBRAL ARTERY (MCA) SIDE WALL ANEURYSM ON (B)(6) 2022. THE HUNT & HESS GRADE WAS 3, THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE TARGET ANEURYSM WAS AS FOLLOWS: HEIGHT 4.1MM, DOME 5.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.2MM, AND DOME-TO-NECK RATIO OF 2.3MM. THE PARENT VESSEL DIAMETER WAS 1.7MM. COIL EMBOLIZATION WAS PERFORMED USING THREE (3) CERENOVUS COILS: A 4MM X 7.5CM MICRUSFRAME 10 ((B)(6)/ 30686615), A 3MM X 4CM GALAXY G3 XSFT ((B)(6)/ 30483248), AND A 2MM X 2CM GALAXY G3 XSFT ((B)(6)/ 30583817) VIA AN SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS DURING THE INDEX PROCEDURE. ON (B)(6) 2023, THE PATI

  Patient problems: Ischemia Stroke

  MAUDE report 17093089 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (B)(6), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830,30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, L16774), MICRUSFRAME10 5MM X 17CM (MFR100517,30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, K10010), GALAXY G3 XSFT 4MM X 10CM (GLX120410, K10380), MICRUSFRAME14 12MM X 30CM (MFR141230, L15281), GALAXY G3 XSFT 3MM X 6CM (GLX120306, L16504), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.5MM X 5CM (GL

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987130 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (B)(6), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830,30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, L16774), MICRUSFRAME10 5MM X 17CM (MFR100517,30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, K10010), GALAXY G3 XSFT 4MM X 10CM (GLX120410, K10380), MICRUSFRAME14 12MM X 30CM (MFR141230, L15281), GALAXY G3 XSFT 3MM X 6CM (GLX120306, L16504), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.5MM X 5CM (GL

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987100 ↗
• MalfunctionFeb 8, 2017Failure to Advance; Failure to Advance

  THE CONTACT FROM THE FACILITY REPORTED THAT WHILE TREATING A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM THE DOCTOR COULD NOT ADVANCE THE MICRUSFRAME COIL (MFR180612/C41978) THROUGH THE LAST 1 CM OF THE DISTAL END OF THE STRYKER XT-17 MICROCATHETER (DETAILS UNKNOWN.) THERE WAS NO VISIBLE DAMAGE TO THIS MICROCATHETER. HE TRIED SEVERAL TIMES AND WAS ABLE TO PULL THE COIL BACK AND ADVANCE, BUT ONCE IT HIT THE SAME SPOT IN THE MICROCATHETER IT WOULD STOP ADVANCING. HE REMOVED THE COIL AND MICROCATHETER AND ACCESSED THE ANEURYSM WITH A NEW XT-17 AND WAS ABLE TO PLACE 6 SPECTRA COILS (DETAILS UNKNOWN) SUCCESSFULLY. THERE WAS NO DELAY GREATER THAN 30 MINUTES DUE TO THE ISSUE. THERE WAS NO DAMAGE TO ANY PART OF THE MICRUSFRAME DEVICE AFTER IT WAS REMOVED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6313168 ↗