MICRUSFRAME MFR100509Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886704077848), received between May 2, 2019 and Sep 22, 2023 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2023Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE PROCEDURE, THE PHYSICIAN OPENED THE PACKAGING FOR THE COMPLAINT DEVICE, A 5MM X 9.7CM MICRUSFRAME 10 (MFR100509 / 30633433) AND IT WAS REPORTED THAT HE FOUND IT DAMAGED AND STRETCHED. THE PRODUCT WAS NOT USED IN THE PATIENT; THERE WAS NO PATIENT CONSEQUENCE. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. ON 11-SEP-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL WAS NO LONGER ATTACHED TO THE DELIVERY SYSTEM. THE REPLACEMENT COIL WAS ANOTHER 5MM X 9.7CM MICRUSFRAME 10 (MFR100509). THERE WAS NO OTHER DAMAGE OBSERVED ON THE COIL OTHER THAN THE STRETCHED CONDITION. THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804840 ↗
• MalfunctionAug 9, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE FIRST COIL, A 5MM X 9.7CM MICRUSFRAME 10 (MFR100509 / 30820694) WAS USED WITH A HEADWAY® 17 MICROCATHETER (MICROVENTION) AND IT REPORTEDLY FAILED TO DETACH. IT WAS REPLACED WITH A 5MM X 17CM MICRUSFRAME 10 (MFR100517 / 30768294), BUT ¿IT WAS STUCK AND COULD NOT BE DELIVERED.¿ IT WAS REPLACED WITH THREE (3) CONSECUTIVE 5MM X 17CM MICRUSFRAME 10 (MFR100517), ONE MORE FROM LOT 30768294 AND TWO (2) FROM LOT 30871999, AND ALL ENCOUNTERED THE SAME ISSUE, BECOMING IMPEDED IN THE MICROCATHETER. THE HEADWAY 17 MICROCATHETER WAS THEN REPLACED WITH AN SL-10® MICROCATHETER (STRYKER). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495448 ↗
• InjuryJun 14, 2023Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 60-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING (CURRENT SMOKER) UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION BRANCH ANEURYSM WITH A HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.4MM, DOME 10.5MM, MAXIMUM ANEURYSM DIAMETER 10.5MM, NECK SIZE 4.9MM, AND DOME-TO-NECK RATIO OF 2.1MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: AN 11MM X 18.9CM MICRUSFRAME 18 (MFR181118 / 30422246), A 5MM X 9.7CM MICRUSFRAME 10 (MFR100509 / 30537019), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / 30379819), A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30624675), AND A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30789543) VIA AN SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE PRINCIPAL INVESTIGATOR (PI), THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE; THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IMMEDIATE POST-PROCEDURE MODIFIED RAYM

  Patient problems: Aneurysm

  MAUDE report 17131998 ↗
• MalfunctionJun 13, 2023Positioning Failure; Positioning Failure

  THE DEVICE MALFUNCTION WAS REPORTED VIA THE STERLING STUDY. ON (B)(6) 2023, THE 42-YEAR-OLD MALE PATIENT WITH A HISTORY OF LUMBAR SPINAL SURGERY UNDERWENT COIL EMBOLIZATION OF A MIDLINE RUPTURED SACCULAR ANEURYSM WITH SPHERICAL MORPHOLOGY IN THE ANTERIOR CIRCULATION (BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY) WITH THE FOLLOWING DIMENSIONS: HEIGHT: 5.5MM, WIDTH: 5.2MM, DEPTH: 4.6MM, NECK: 2.5MM, MAXIMUM ANEURYSM DIAMETER 6.8. DOME-TO-NECK RATIO 2.1. THE 5MM X 9.7CM MICRUSFRAME 10 (MFR100509 / 30656522) WAS PLACED VIA AN SL-10® MICROCATHETER (STRYKER). ANGIOGRAPHY SHOWED HERNIATION / PROLAPSE OF COIL INTO THE LEFT A1/A2 JUNCTION. THE COIL WAS REMOVED AND RESHEATHED. IT WAS REPLACED WITH A 4MM X 8CM TARGET XL 360 SOFT (STRYKER), WHICH WAS USED TO FRAME THE ANEURYSM. THE FOLLOWING COILS WERE SUBSEQUENTLY IMPLANTED: 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30637469), 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / 30830578), 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / 30830578), 2.5MM X 4.5CM GALAXY G3 MINI (GLM925045 / 30727829), 2MM X 4CM GALAXY G3 MINI (GLM920040 / 30768284), 2MM X 3MM GALAXY G3 MINI (GLM920030 / 30790686), AND 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025 / 30419306). THERE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122342 ↗
• MalfunctionMay 10, 2023Stretched; Stretched

  AS REPORTED BY THE FIELD, PRIOR TO USE, A MICRUSFRAME10 5MM X 9.7CM COIL (MFR100509, 30537018) CAME OUT OF THE PACKAGING FRAYED. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903627 ↗
• MalfunctionOct 18, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A STENT ASSIST COIL EMBOLIZATION OF RECURRENT RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. DURING THE PROCEDURE A 5MM X 9.7 CM MICRUSFRAME10 (MFR100509, 30498377) WAS SELECTED AND PREPPED FOR USE. ONCE IN POSITION, THE COIL WOULD NOT DETACH AND WAS DEEMED TO BE DEFECTIVE. IT WAS REMOVED FROM SERVICE AND SAVED FOR INVESTIGATION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624344 ↗
• InjuryApr 23, 2021Positioning Problem; Migration; Positioning Problem; Migration

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE (CAD), MYOCARDIAL INFARCTION, AND SMOKING (PREVIOUS) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM ON (B)(6) 2021. THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 7MM, DOME 4.5MM, MAXIMUM ANEURYSM DIAMETER 5.5MM, NECK SIZE 4MM, AND DOME-TO-NECK RATIO 1.1MM. THE PARENT VESSEL DIAMETER WAS 4MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE 5MM X 9.7CM MICRUSFRAME10 COIL (MFR100509 / K10306), THREE 1.5MM X 4CM DELTAFILL10 (L11514, L10334, & L11298), TWO 2MM X 8CM DELTAFILL10 (K10471 & L17092), AND ONE 3MM X 8CM DELTAFILL10 (L16549) VIA AN EXCELSIOR® XT-17¿ MICROCATHETER (STRYKER). A SINGLE LOOP OF THE 5MM X 9.7CM MICRUSFRAME10 COIL MINIMALLY PROLAPSED INTO THE PARENT VESSEL DURING THE PROCEDURE. THE COIL WAS REPORTEDLY DETACHED IN A GOOD POSITION, BUT THE PROLAPSE STARTED AFTER FILLING THE ANEURYSM WITH THE THIRD COIL AND PROCEEDED GRADUALLY UNTIL THE SEVENTH AND LAST COIL. THE PHYSICIAN ATTEMPTED TO CORRECT THE COIL POSITION WITH A 4MM X 10MM SCEPTER BALLOON CATHETER (M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11719563 ↗
• InjuryApr 6, 2020Separation Failure; Premature Separation; Separation Failure; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN EMERGENCY COIL EMBOLIZATION OF A RUPTURED POSTERIOR CEREBRAL ARTERY ANEURYSM, A 5MM X 9.7CM MICRUSFRAME10 WAS POSITIONED IN THE ANEURYSM AS THE FIRST COIL, BUT THE COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED SEVERAL TIMES WITH DIFFERENT POSITIONING OF THE COIL TO THE MICROCATHETER AND WITH LESS LOAD ON THE MICROCATHETER. IN THE END, THE PHYSICIAN WITHDREW THE COIL, BUT THE COIL DETACHED AFTER IT WAS ABOUT 3CM IN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PUSH THE DETACHED COIL FULLY IN THE ANEURYSM SAC. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT AND THERE WAS NO PROCEDURAL DELAY. THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED WITHOUT INCIDENT. IT WAS LAST REPORTED THAT THE PATIENT IS DOING OKAY AND IS INTUBATED FROM HIS PRESENTING SUBARACHNOID HEMORRHAGE (SAH). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. NO FURTHER RELEVANT INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: No Code Available

  MAUDE report 9928194 ↗
• MalfunctionJan 13, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED SOME ISSUES WITH THE 5MM X 9.7CM MICRUSFRAME 10 COIL (MFR100509 / L15937). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE 5MM X 9.7CM MICRUSFRAME 10 COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED. BASED ON THE PRODUCT ANALYSIS ON 1/13/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583593 ↗
• 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 5MM X 9.7CM MICRUSFRAME 10 COIL (MFR100509 / L11759) 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 5MM X 9.7CM 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 8628935 ↗
• MalfunctionMay 2, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN 8.8MM SACCULAR ANEURYSM ON THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH THE FOLLOWING DIMENSIONS: 4.6MM HEIGHT, 8.5MM LENGTH, AND A NECK SIZE OF 2.8MM, THE 5MM X 9.7CM MICRUSFRAME 10 COIL (MFR100509 / L14765) WAS ONE OF THE COILS USED. IT FAILED TO DETACH AFTER THREE DETACHMENT ATTEMPTS WERE MADE. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT AND THE FAULT LIGHT WAS NOT SEEN DURING THE CASE. THE AUDIBLE SIGNAL BEEP WAS HEARD BUT THE PHYSICIAN COULD NOT RECALL IF THE GREEN SYSTEM READY LIGHT WAS ILLUMINATED AND DID NOT KNOW IF THE DETACHMENT LIGHT WAS ILLUMINATED. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED; THERE WAS NO DAMAGE NOTED ON THE COIL, THE COIL AND ON THE COIL DELIVERY SYSTEM PRIOR TO USE AND AFTER REMOVAL. IT WAS CONFIRMED THAT THERE WERE NO KINKS ON THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION ASSOCIATED WITH THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE IMPLANTATION OF SEVERAL OTHER COILS USING THE SAME

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575910 ↗