MICRUSFRAME MFR100356Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704077794), received between Nov 15, 2018 and Apr 11, 2022 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2022Deformation 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 (B)(6) FEMALE PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE (CAD)U, DEEP VEIN THROMBOSIS (DVT) / PULMONARY EMBOLISM (PE), CONTROLLED HYPERTENSION, SMOKING (PREVIOUS), ACUTE KIDNEY FAILURE, INTRACRANIAL ANEURYSMS (TOTAL OF 3 INCLUDING TARGET), CLASS 3 OBESITY (BMI 41 KG/M2), AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM WITH HUNT & HESS GRADE 2 ON (B)(6) 2020. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 4.4MM, DOME 4.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.7MM, AND DOME-TO-NECK RATIO OF 1.5MM. THE PARENT VESSEL DIAMETER WAS 1.1MM. COIL EMBOLIZATION WAS PERFORMED WITH THE FOLLOWING SIX (6) CERENOVUS SPECTRA COILS: A 3.5MM X 6.6CM MICRUSFRAME 10 (MFR100356 / L12781), A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / L14864), A 1.50MM X 2.50CM GALAXY G3 MINI (GLM915025 / L15547), A 1.00MM X 1.50CM GALAXY G3 MINI (GLM910015 / L13801), A 2.00MM X 3.00CM GALAXY G3 MINI (GLM920030 / 30379812), A 1.50MM X 2.50CM GALAXY G3 MINI (GLM915025 / L13691), AND ONE (1) COMPETITOR COIL, A 1.5MM X 2CM TARGET HELICAL NANO COIL (STRYKE

  Patient problems: Aneurysm

  MAUDE report 14079108 ↗
• MalfunctionFeb 25, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE COIL INTRODUCER SHEATH ON THE 3.5MM X 6.6CM MICRUSFRAME 10 COIL (MFR100356 / L15877) WAS TORN WHEN THE COIL ENTERED THE MICROCATHETER. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE PHOTO WAS REVIEWED BY THE PRODUCT ANALYSIS LAB. IT CAN BE OBSERVED THAT THE DEVICE POSITIONING UNIT (DPU) WAS PROTRUDING FROM THE INTRODUCER. ONLY A PORTION OF THE DEVICE AS SHOWN ON THE PHOTO, THE REST OF THE DEVICE WAS NOT CAPTURED. BASED ON THE PHOTO, THE REPORTED TORN COIL INTRODUCER WAS CONFIRMED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS AVAILABLE AT A LATER DATE AND THE PRODUCT IS RETURNED, THE FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE DPU WAS OBSERVED TO BE MECHANICALLY BROKEN. BASED ON THE PRODUCT ANALYSIS ON 23 FEBRUARY 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382613 ↗
• InjuryDec 31, 2020Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE 3.5MM X 6.6CM MICRUSFRAME 10 COIL (MFR100356 / LOT# UNKNOWN) WAS IMPLANTED. IT BECAME ENTANGLED WITH THE 2.50MM X 4.50CM GALAXY G3 MINI COIL (GLM925045 / 30383054) AND CAME OUT OF THE ANEURYSM. IT WAS RETRIEVED THROUGH A BALLOON CATHETER. THERE WAS NO REPORT OF ANY BLOOD FLOW RESTRICTION OR REDUCTION AS A RESULT OF THE ISSUE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING STRYKER COILS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102346 ↗
• 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 8754756 ↗
• InjuryApr 1, 2019Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE (B)(6) MALE PATIENT WITH A HISTORY OF HEADACHES, HYPERTENSION, AND SUBARACHNOID HEMORRHAGE OF A NON-TARGET ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) ON (B)(6) 2019, UNDERWENT TREATMENT OF A SECOND RIGHT MCA ANEURYSM. ANGIOGRAPHY REVEALED A MULTILOBULATED, IRREGULARLY SHAPED UNRUPTURED ANEURYSM AT THE RIGHT MCA BIFURCATION. THE PARENT VESSEL WAS 2.2 MM, ANEURYSM HEIGHT WAS 5.3 MM, AND THE DOME WAS 3.2 MM. THE MAXIMUM ANEURYSM DIAMETER WAS 5.6 MM, THE ANEURYSM NECK SIZE WAS 3.8 MM, AND THE DOME TO NECK RATIO WAS 0.8. THE PATIENT¿S PRE-PROCEDURE MRS SCORE WAS A 2. THE COIL EMBOLIZATION WAS PERFORMED AND THE 3.5MM X 6.6 CM MICRUSFRAME 10 COIL (MFR100356 / L10260) WAS IMPLANTED. A COUPLE OF THE COIL LOOPS FROM THIS COIL SLIGHTLY MOVED AND BECAME SLIGHTLY PROTRUDED INTO THE PARENT VESSEL. THE PATIENT EXPERIENCED ASYMPTOMATIC THROMBUS FORMATION IN THE RIGHT SUPERIOR MCA THAT WAS PARTIALLY OCCLUSIVE. THE SOURCE OF THE THROMBUS WAS REPORTED TO BE NEAR THE PROTRUDING COIL RESULTING IN THE NARROWING OF THE PARENT VESSEL. THE ADVERSE EVENT WAS CONSIDERED SERIOUS AND WITH A SEVERITY OF SEVERE. THE THROMBUS FORMATION EVENT RESOLVED DURING TH

  Patient problems: No Code Available; Thromboembolism

  MAUDE report 8469811 ↗
• MalfunctionJan 16, 2019Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE INTERNAL CAROTID ARTERY, THE 4 MM X 7.5 CM MICRUSFRAME 10 COIL (MFR100356 / S13055) WAS DELIVERED INTO THE STRYKER SL-10® MICROCATHETER BUT THERE WAS RESISTANCE BETWEEN THE HUB OF THE MICROCATHETER AND THE COIL. THE COIL WAS RETRACTED ONCE AND REDELIVERED INTO THE MICROCATHETER, BUT RESISTANCE WAS EXPERIENCED AT 10 CM FROM THE TIP OF THE MICROCATHETER AND THE COIL COULD NOT BE ADVANCED FURTHER. THE MICRUSFRAME 10 COIL WAS REPLACED WITH ANOTHER OF THE SAME SIZE FROM THE SAME LOT S13055. THE REPLACEMENT COIL WAS DELIVERED TO THE TARGET LESION USING THE SAME MICROCATHETER WITHOUT ANY ISSUE; HOWEVER, THE SIZE OF THE COIL DID NOT FIT THE LESION AND IT WAS REPLACED. 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 NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WAS RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253914 ↗
• MalfunctionNov 15, 2018Stretched; Component Misassembled; Premature Separation; Stretched; Component Misassembled; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, RESHEATHING OF THE 3.5MM X 6.6CM MICRUSFRAME10 (MFR100356/L10187) THERMO-MECHANICAL COIL WAS NOT POSSIBLE SINCE THE COIL HAD STRETCHED. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SIGNIFICANT DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073787 ↗