MICRUSFRAME MFR100412Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886704077817), received between Jul 12, 2018 and Aug 6, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), A MICRUSFRAME10 4MM X 11.5CM COIL (MFR100412, 0552501S) WAS RELEASED WITH DIFFICULTY FROM THE SHEATH, SEEMINGLY RUBBING. IT CANNOT BE FULLY DEPLOYED, AND IT WAS WITHDRAWN. NO HARM WAS CAUSED TO THE PATIENT. THE SURGERY WAS DELAYED BY TWO MINUTES. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 18-JUL-2025 INDICATING THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE COIL WAS NOT INSERTED INTO THE PATIENT WITH DIFFICULTY. IT WAS CONFIRMED THAT THE COIL ATTEMPTED TO BE DETACHED BUT FAILED. A PHENON 17 MICROCATHETER WAS USED. IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THERE WAS NOTHING SPECIAL ABOUT THE PATIENT ANATOMY OR VESSEL CHARACTERISTICS. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. A CONTINUOUS FLUSH WAS MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727766 ↗
• MalfunctionJul 8, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  THE HEALTHCARE PROFESSIONAL REPORTED AN ISSUE WITH TWO (2) COILS: A 4MM X 11.5CM MICRUSFRAME 10 (MFR100412 / 31073024) AND A 7MM X 30CM MICRUSFRAME 10 (MFR100730 / 30762308) THAT COULD NOT BE REMOVED DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE. IT WAS REPORTED THAT ADDITIONAL INFORMATION RELATED TO THE COMPLAINT IS NOT AVAILABLE. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSES. THE PRODUCT INVESTIGATIONS WERE COMPLETED ON 08-JUL-2025. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THE PRODUCT INVESTIGATION RELATED TO THE 4MM X 11.5CM MICRUSFRAME 10 (MFR100412 / 31073024) MEETS REPORTABILITY CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22449360 ↗
• MalfunctionJan 26, 2022Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY THE FIELD, A MICRUSFRAME10 COIL 4MM X 11.5CM (MFR100412, 30508792) WAS BENT. THEY OPENED ANOTHER COIL ONE AND CONTINUED WITHOUT INCIDENT. THERE WAS NO SURGERY DELAYED DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359367 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) STUDY, A (B)(6) FEMALE ((B)(6)) WITH A HISTORY OF ACTIVE SMOKING AND INTRACRANIAL ANEURYSM UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2021 AND EXPERIENCED INTRAOPERATIVE ANEURYSM PERFORATION. BALLOON OCCLUSION WAS PERFORMED AS INTERVENTION, AND THE EVENT REQUIRED PROLONGED HOSPITALIZATION. THE PATIENT IS RECOVERING FROM THE EVENT. THE EVENT WAS CLASSIFIED AS SEVERE. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS RELATED TO THE STUDY DEVICE. THE EVENT WAS CONSIDERED SERIOUS.

  Patient problems: Aneurysm

  MAUDE report 13010248 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE (B)(6)-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF DIABETES, UNCONTROLLED HYPERTENSION, UNCONTROLLED HYPERLIPIDEMIA, HEADACHES, MIGRAINES, SLEEP APNEA, TUBAL LIGATION, ROSACEA, FATTY LIVER, HERPES ZOSTER, BENIGN PAROXYSMAL VERTIGO, AND CLASS 2 OBESITY (BMI 37 KG/M2) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED AN UNRUPTURED RIGHT MCA BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSION: HEIGHT 4.9MM, DOME 5.2MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO 1.6MM. THE PARENT VESSEL DIAMETER WAS 1.5MM. THE PATIENT UNDERWENT COIL EMBOLIZATION WITH THE IMPLANTATION OF ONE 4MM X 11.5CM MICRUS-FRAME 10 COIL (MFR100412 / L10083), ONE 3MM X 6CM GALAXY G3 COIL (GLY120306 / L12402), ONE 2.5MM X 5CM GALAXY G3 COIL (GLY122505 / L11547), ONE 1.5MM X 4CM DELTA-FILL 10 COIL (DLF100154 / UNKNOWN LOT NUMBER), AND ONE 1.5MM X 1CM DELTAXSFT 10 COIL (DLXA100151 / UNKNOWN LOT NUMBER) VIA A HEADWAY DUO MICROCATHETER (MICRO-VENTION) MICROCATHETER. A NEURO-FORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED FOR NECK REMODELING. H

  Patient problems: Infarction, Cerebral; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10824561 ↗
• InjuryMar 19, 2020Migration; Migration

  A REPORT FROM THE FIELD INDICATED THAT APPROXIMATELY ONE MONTH FOLLOWING A COIL EMBOLIZATION OF AN UNRUPTURED PARACLINOID INTERNAL CAROTID ARTERY ANEURYSM WITH A 4MM X 11.5CM MICRUSFRAME10 (MFR100412/S13585) AND TWO COMPETITOR COILS, ¿SOME SUBSTANCE OTHER THAN THROMBUS WAS FLYING TO THE PERIPHERY¿. THE PHYSICIAN SUSPECTED THAT THE SUBSTANCE WAS THE IMPLANTED MICRUSFRAME10 COIL AS IT WAS NOT SEEN AFTER THE PROCEDURE. THE PATIENT HAS NOT EXPERIENCED ANY CLINICAL SYMPTOMS AS A RESULT OF THE EVENT. THE COIL EMBOLIZATION PROCEDURE OCCURRED ON (B)(6) 2020. IT WAS STATED THAT IT WAS VERY DIFFICULT TO DELIVER THE MICROCATHETER TO THE TARGET ANEURYSM DURING THE PROCEDURE; SL-10 (STRYKER) AND HEADWAY17 (TERUMO) MICROCATHETERS WERE UTILIZED. THE COMPLAINT COIL IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: No Code Available

  MAUDE report 9853204 ↗
• MalfunctionJul 30, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH THE TARGET LESION ON THE LEFT CAROTID ARTERY / CAVERNOUS SACRIFICE, THE 4MM X 11.5CM MICRUSFRAME 10 COIL (MFR100412 / L11087) WAS ADVANCED INTO THE ANEURYSM THROUGH THE SL-10® MICROCATHETER (STRYKER) AND WAS IN THE PROCESS OF BEING DETACHED. THE DETACHMENT WAS NOT COMPLETE WHEN THE COIL WAS PULLED BACK INTO THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT¿S BODY AND IT DETACHED ON THE FIELD AFTER IT WAS REMOVED FROM THE PATIENT¿S BODY AND FROM THE MICROCATHETER. IT WAS REPORTED THAT THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED, AND THE DETACHMENT ON THE SURGICAL FIELD AFTER REMOVAL FROM THE PATIENT¿S BODY DID OCCUR AT THE DETACHMENT ZONE. THE COIL WAS USED WITH THE ENPOWER DETACHMENT CONTROL BOX (DCB) WITH THE ENPOWER CONTROL CABLE. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE; THE SAME ENPOWER DCB AND ENPOWER CONTROL CABLE WERE USED TO DETACH SUBSEQUENT COILS. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROCEDURAL DELAY; THE REPORTED ISSUE DID NOT ALTER THE CASE PLAN. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844047 ↗
• MalfunctionMay 8, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 4MM X 11.5CM MICRUSFRAME 10 COIL (MFR100412 / L11133) HAD A PRESCORE RUPTURE AND PREMATURE PEELING OF THE COIL INTRODUCER WHICH CAUSED THE COIL AND THE DEVICE POSITIONING UNIT (DPU) TO BECOME EXPOSE; THE COIL PROTRUDED FROM THE COIL INTRODUCER. THERE WAS NO DAMAGE NOTED ON THE PORTION OF THE COIL THAT WAS EXPOSED. IT WAS REPORTED THAT THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY; THE COIL WAS REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM. ANOTHER REPLACED THE DEVICE. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC); THERE WAS NO DAMAGE TO THE MICROCATHETER, THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. THE PRODUCT WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE 4MM X 11.5CM MICRUSFRAME 10 COIL WAS IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 5/6/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592196 ↗
• MalfunctionMar 14, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A GASTROINTESTINAL HEMORRHAGE, THE CONCOMITANT MICROCATHETER (PROGREAT® - TERUMO) WAS DELIVERED TO THE TARGET LESION AND THE COIL EMBOLIZATION PROCEDURE STARTED. THE 4MM X 11.5CM MICRUSFRAME 10 COIL (MFR100412 / S12577) WAS THE SECOND (REPLACEMENT) COIL USED, IT WAS REPLACING THE FIRST 4MM X 11.5CM MICRUSFRAME 10 COIL (MFR100412 / S12911) THAT WAS INSERTED IN TO THE MICROCATHETER AND WAS MET WITH STRONG RESISTANCE. THIS SECOND (REPLACEMENT) MICRUSFRAME 10 COIL ALSO ENCOUNTERED STRONG RESISTANCE IN THE MICROCATHETER LIKE THE FIRST COIL. THE PHYSICIAN CHOSE ANOTHER COIL, A GALAXY G3 COIL AND IT WAS IMPLANTED WITHOUT ANY ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. IT WAS CONFIRMED THAT THERE WAS NO BENT OR KINK ON THE MICROCATHETER PRIOR TO USE. THERE WAS NO BENT OR KINK ON THE COIL PRIOR TO THE PROCEDURE. THE TARGET VESSEL WAS NOT TORTUOUS OR WITH ACUTE BENDS. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8421018 ↗
• MalfunctionMar 14, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A GASTROINTESTINAL HEMORRHAGE, THE CONCOMITANT MICROCATHETER (PROGREAT® - TERUMO) WAS DELIVERED TO THE TARGET LESION AND THE COIL EMBOLIZATION PROCEDURE STARTED. THE 4MM X 11.5CM MICRUSFRAME 10 COIL (MFR100412 / S12911) WAS INSERTED INTO THE MICROCATHETER, BUT THE COIL ENCOUNTERED STRONG RESISTANCE. THE COIL WAS REPLACED WITH ANOTHER 4MM X 11.5CM MICRUSFRAME 10 COIL (MFR100412 / S12577) AND THE SAME ISSUE WITH RESISTANCE WAS ENCOUNTERED WITH THIS REPLACEMENT COIL. ANOTHER COIL, A GALAXY G3 WAS USED AND THE G3 COIL WAS IMPLANTED WITHOUT ANY ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. IT WAS CONFIRMED THAT THERE WAS NO BENT OR KINK ON THE MICROCATHETER PRIOR TO USE. THERE WAS NO BENT OR KINK ON THE COIL PRIOR TO THE PROCEDURE. THE TARGET VESSEL WAS NOT TORTUOUS OR WITH ACUTE BENDS. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420938 ↗
• MalfunctionJul 12, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT UPON DEPLOYMENT OF TWO MICRUSFRAME 10 COILS (MFR100412/L10195 AND 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 AND MFR100407/L10192

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7683585 ↗