MICRUSFRAME MFR100407Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886704077824), received between Jul 12, 2018 and Jul 24, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2024Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A CEREBRAL ANEURYSM, THREE COILS WERE USED: A 2MM X 4CM GALAXY G3 XSFT HELICAL (GLX120204 / 30692213), A 3MM X 6CM GALAXY G3 (GLY120306 / 30618612), AND A 4MM X 7.5CM MICRUSFRAME 10 (MFR100407 / 30396193). IT WAS REPORTED THAT THE TWO GALAXY G3 COILS ENCOUNTERED FRICTION AND COULD NOT BE RE-SHEATHED. THE MICRUSFRAME COIL ¿DID NOT SLIDE INTO THE CATHETER WITH TOO MUCH FRICTION AND DID NOT GO INTO THE MICROCATHETER.¿ IT WAS REPORTED THAT ¿ANOTHER COIL WAS USED PERFECTLY WITH NO FRICTION NOTICED.¿ THERE WAS NO NEGATIVE PATIENT IMPACT. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSES COMPLETED ON 24-JUL-2024, THE MICRUSFRAME COIL WAS OBSERVED KINKED. THIS OBSERVED MALFUNCTION MEETS USFDA REPORTING CRITERIA AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822240 ↗
• MalfunctionMay 9, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THE USER USED A MICRUSFRAME10 4MM X 7.5CM COIL (MFR100407, 30824748) BUT THE ENPOWER DCB 2 SYSTEM DIDN'T WORK (APPARENTLY THE BATTERY RAN OUT, WHICH IS QUITE AN EXPECTED SITUATION) AND THE COIL WAS LEFT UNPLACED IN THE PATIENT. THE SALES REPRESENTATIVE CHECKED THE DCB AND THE LIGHTS WORKED (THE BATTERY IS FULL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894366 ↗
• InjuryApr 7, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  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 15-DEC-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 (MFR100407 / 30686615), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / 30483248), AND A 2MM X 2CM GALAXY G3 XSFT (GLX120202 / 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 05-JAN-20

  Patient problems: Aneurysm

  MAUDE report 16704324 ↗
• InjuryAug 10, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEADACHES, CONTROLLED HYPERTENSION, ACTIVE SMOKING, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND RHEUMATOID ARTHRITIS UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM ON (B)(6) 2020. 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSMAL SAC. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. A PIPELINE FLOW DIVERTER WAS IMPLANTED DUE TO INCREASE IN ANEURYSM SIZE ON (B)(6) 2021. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. MODIFIED RAYMOND-ROY CLASSIFICATION FOR THE TARGET ANEURYSM FOLLOWING RETREATMENT WAS CLASS II. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED AN UNRUPTURED ANEURYSM ON THE RIGHT SIDEWALL OF THE ICA WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.5MM, DOME 5.9MM, MAXIMUM ANEURYSM DIAMETER 5.9MM, NECK SIZE 3.0MM, AND DOME-TO-NECK

  Patient problems: Aneurysm

  MAUDE report 12302334 ↗
• MalfunctionOct 13, 2020Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4MM X 7.5CM MICRUSFRAME 10 COIL (MFR100407 / L11516) WAS USED DURING A PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM). IT WAS REPORTED THAT THE VESSEL WAS MODERATELY TORTUOUS. THE COMPLAINT COIL FAILED TO DETACH DURING THE DETACHMENT ATTEMPT, IT BECAME DETACHED DURING RETRACTION AND WAS PUSHED INTO THE ANEURYSM. THE COIL DID NOT BECOME FRACTURED INTO SEPARATE PIECES. THE SAME MICROCATHETER HAD BEEN USED ON PREVIOUS COILS. THE EVENT DID NOT RESULT IN ANY REDUCED OR RESTRICTED BLOOD FLOW IN THE PARENT VESSEL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10672098 ↗
• MalfunctionAug 4, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 4MM X 7.5CM MICRUSFRAME10 COIL (MFR100407, L14990) WAS BEING USED AS THE FIRST COIL. HOWEVER, THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10361857 ↗
• MalfunctionMay 14, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CEREBRAL ANEURYSM COIL EMBOLIZATION PROCEDURE, THE 4MM X 7.5CM MICRUSFRAME 10 COIL (MFR100407 / L16348) GOT STUCK IN THE CONCOMITANT MICROCATHETER AND WOULD ADVANCE ANY FURTHER. IT WAS REPORTED THAT THE COIL WAS PREPPED CORRECTLY AND UPON REMOVAL, THE SALES REPRESENTATIVE NOTICED THAT THE DISTAL END OF THE DELIVERY WIRE OR DEVICE POSITIONING UNIT (DPU) THAT IS PROXIMAL TO THE ACTUAL COIL WAS KINKED. THE GREEN PART OF THE DELIVERY SYSTEM WAS NOT UP AGAINST THE HUB. ANOTHER 4MM X 7.5CM MICRUSFRAME 10 COIL WAS USED AND IT GOT STUCK AS WELL, BUT THE GREEN PART OF THE DELIVERY SYSTEM WAS RELOCATED BACK UP NEXT TO THE CONNECTOR HUB AND IT WAS ABLE TO BE COMPLETELY PUSHED OUT AND DELIVERED INTO THE ANEURYSM AND DEPLOYED SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT COMPLICATION OR PROCEDURAL DELAY. A PHOTO OF THE COMPLAINT DEVICE WAS SENT BACK ON 30 MARCH 2020 BY THE SALES REPRESENTATIVE. BASED ON THE PHOTO PROVIDED, THE PRODUCT ANALYSIS TEAM REVIEWED THE PHOTO. IT CAN BE DETERMINED THAT THE 4MM X 7.5CM MICRUSFRAME 10 COIL HAS A KINK AREA ON THE DISTAL SECTION OF THE DPU. THE COMPLAINT DEVICE WAS RETURNED FO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10059857 ↗
• MalfunctionMay 21, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED VIA THE STERLING STUDY DURING THE ENDOVASCULAR COILING PROCEDURE TARGETING A CHALLENGING WIDE-NECKED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM WITH INCORPORATION OF BOTH M2 BRANCHES, AFTER THE SUPERIOR M2 BRANCH WAS STENTED, THE 4MM X 7.5CM MICRUSFRAME 10 COIL (MFR100407 / L11516) WAS ONE OF THE COILS THAT WAS OPENED, INSERTED, AND DEPLOYED IN THE ANEURYSM BUT WAS NOT DETACHED. PER THE PHYSICIAN, INITIAL COIL PLACEMENT IS CRITICAL IN THESE CASES AS THE FRAMING COIL MUST BE POSITIONED JUST RIGHT TO ENSURE THAT THE UNPROTECTED M2 (INFERIOR BRANCH) DOES NOT BECOME OVERLY IMPINGED ON BY COIL. THE PHYSICIAN WAS NOT SATISFIED WITH HOW THE 4MM X 7.5CM MICRUSFRAME 10 COIL CONFORMED TO THE ANEURYSM WALL AND REMOVED THE COIL FROM THE PATIENT. THE COIL WAS NOT USED; THERE WAS NO DAMAGE TO THE COIL OR COIL INTRODUCER WHEN IT WAS REMOVED FROM THE PATIENT. PER THE PHYSICIAN, THIS INITIAL FRAMING COIL PLACEMENT WAS A TRIAL AND ERROR APPROACH AND IS THUS, NOT INDICATIVE OF ANY COIL DEFECT. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT; THE REPORTED EVENT DID RESULT IN A 5-MINUTE PROCEDURAL DELAY THAT W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628941 ↗
• MalfunctionJul 12, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT UPON DEPLOYMENT OF TWO MICRUSFRAME 10 COILS (MFR100412/L10195 & MFR100407/L10192) THE PHYSICIAN NOTED DEFLECTION. HE USED DIFFERENT COILS DURING THE SAME CASE AND THE DEVICES WORKED AS EXPECTED WITHOUT DEFLECTION OF THE MICROCATHETER. THE PHYSICIAN DOES NOT BELIEVE THAT THE ANATOMY OF THE CATHETER POSITION HAD CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, DURING DEPLOYMENT OF A DELTAFILL COIL ( DFL181040/L10137), IT WAS NOTED THAT THE DETACHMENT DID NOT TAKE PLACE AS THE COIL ACTUALLY PULLED BACK WITH THE DELIVERY WIRE ON ATTEMPTED RETRIEVAL OF THE DELIVERY WIRE, AFTER THE DETACHMENT BUTTON HAD BEEN PRESSED WITH THE CORRESPONDING/EXPECTED BEEP AND LIGHT INDICATORS. A COUPLE OF ADDITIONAL DETACHMENT ATTEMPTS WERE REQUIRED, BEFORE THE COIL EVENTUALLY DETACHED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. NOTE: THIS EVENT WAS DEEMED MDR REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON JUNE 13, 2018. ADDITIONAL INFORMATION RECEIVED ON JUNE 13, 2018: DURING AN EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY, THE MICRUSFRAME COILS COLD NOT BE DETACHED (MFR100412/L10195 & MFR100407/L10192).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7683595 ↗