MICRUSFRAME MFR181137Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886704078074), received between Nov 20, 2017 and Oct 2, 2023 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE 64-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CONTROLLED HYPERLIPIDEMIA, CONTROLLED HYPERTENSION, SMOKING (CURRENT), AND INTRACRANIAL ANEURYSMS (TOTAL OF 3) PRESENTED WITH A SUBARACHNOID HEMORRHAGE (SAH) SECONDARY TO RUPTURED ANEURYSM (HUNT & HESS GRADE 2) AND SUBSEQUENTLY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED ANEURYSM ON THE LEFT SIDEWALL OF THE INTERNAL CAROTID ARTERY (ICA): HEIGHT: 10MM, DOME: 12MM, MAXIMUM ANEURYSM DIAMETER: 17MM, NECK SIZE: 7.8MM, AND DOME-TO-NECK RATIO: 1.5MM. THE PARENT VESSEL DIAMETER WAS 5.8MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF THE FOLLOWING COILS: A 14MM X 47CM MICRUSFRAME18 COIL (MFR181447 / L10314), A 11MM X 37CM MICRUSFRAME18 COIL (MFR181137 / L10312), A 10MM X 30CM GALAXY G3 COIL (GLY121030 / L11083), AND A 9MM X 25CM GALAXY G3 COIL (GLY120925 / L10732) VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). AN 8MM X 24CM GALAXY G3 COIL (GLY120824 / L15747) WAS USED BUT NOT IMPLANTED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17857069 ↗
• MalfunctionAug 16, 2023Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A MICRUSFRAME18 11MM X 37CM COIL (MFR181137, 30537032) WAS ADVANCED INTO A SL10 BY STRYKER MICROCATHETER, RESISTANCE WAS NOTED AFTER ADVANCING COIL THROUGH THE DOCKING POINT OF THE INTRODUCER SHEATH AND RHV AND WOULD NOT ADVANCE FURTHER INSIDE MID SHAFT OF THE MICROCATHETER. WHEN PULLING BACK COIL, COIL DETACHED INSIDE MICROCATHETER AND COULD NOT BE REMOVED. THE COIL AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT AND REASSESSED WITH NEW MICROCATHETER AND COIL. THE SURGERY WAS DELAYED BY 5 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. INITIALLY, THE COIL WAS THE FIRST DEVICE ADVANCED THROUGH THE MICROCATHETER (MC) AFTER THE MICRO GUIDEWIRE WAS TAKEN OUT. A CONTINUOUS FLUSH WAS USED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING COIL ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17556624 ↗
• MalfunctionJul 24, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EXTERNAL CAROTID ARTERY EMBOLIZATION DUE TO A GUNSHOT WOUND, THE PHYSICIAN ENCOUNTERED ISSUES WITH FOUR (4) COILS. THE FIRST TWO COILS, A 11MM X 37CM MICRUSFRAME 18 (MFR181137 / 30537032) AND A 12MM X 40CM MICRUSFRAME 18 (MFR181240 / 30670821) WOULD NOT DETACH AFTER MORE THAN FIVE (5) CYCLES WERE MADE TO ATTEMPT TO DETACH THEM. THE THIRD COIL, A 1.5MM X 2CM DELTAXSFT 10 (DLX100152 / 30633423) AND THE FOURTH COIL, A 1.5MM X 3CM DELTAXSFT 10 (DLX100153 / 30652463) WOULD NOT ADVANCE DUE TO BROKEN STRING ON THE LOCK MECHANISM. THE PHYSICIAN MOVED TO A DIFFERENT PRODUCT TO FINISH THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON 13-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PATIENT IS A MALE UNDER 18 YEARS OF AGE. THE CONCOMITANT MICROCATHETER USED FOR ALL THE COILS WAS A 0.017 ID HEADWAY® DUO 156 MICROCATHETER (MICROVENTION). THE ADDITIONAL INFORMATION RELATED TO THE 11MM X 37CM MICRUSFRAME 18 (MFR181137 / 30537032) INDICATED THE FOLLOWING: THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. A PRE-DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379487 ↗
• MalfunctionMay 18, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 11MM X 37CM MICRUSFRAME18 COIL (MFR181137, 30415698) WAS INSERTED CORRECTLY, BUT ALREADY WITH DIFFICULTY. THE COIL REACHED THE ANEURYSM, THEN COULD NOT BE PUSHED FURTHER. WHEN PULLED BACK, THE COIL STRETCHED JUST BEFORE THE END. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841423 ↗
• InjurySep 11, 2019Migration or Expulsion of Device; Detachment of Device or Device Component; Positioning Problem; Migration or Expulsion of Device; Detachment of Device or Device Component; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, AN ATLAS STENT WAS PLACED FROM THE LEFT SIDE AND AN 11MM X 37CM MICRUSFRAME18 COIL WAS THEN FULLY DEPLOYED INTO THE ANEURYSM SAC, BUT THE COIL MASS PARTIALLY HERNIATED INTO THE PARENT VESSEL. ADDITIONAL 6F ACCESS WAS OBTAINED AT THE RIGHT FEMORAL ARTERY. THE PHYSICIAN ATTEMPTED TO PASS A MICROCATHETER FROM THE RIGHT INTERNAL CAROTID ARTERY (ICA) TO THE OPPOSITE ANTERIOR CEREBRAL ARTERY (ACA) VESSEL TO PLACE A SECOND ATLAS STENT, BUT THE COIL MASS WAS IN THE PATH OF THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE COIL TO PLACE THE STENT ACROSS THE OPPOSITE ACA, BUT THE COIL COULD NOT BE PULLED BACK INTO THE SL-10 (STRYKER) MICROCATHETER BECAUSE IT HAD PREMATURELY DETACHED IN THE MICROCATHETER. THE PHYSICIAN HAD PLANNED ON DETACHING THE COIL AFTER DEPLOYING THE SECOND ATLAS STENT, BUT HE WAS UNABLE TO ADVANCE THE MICROCATHETER PAST THE COIL MASS INTO THE OTHER A1 BRANCH. THE COIL WAS LEFT PARTIALLY PROTRUDING FROM THE ANEURYSM INTO THE PARENT ARTERY, RESULTING IN LEFT A2 CLOT FORMATION. THE CLOT WAS TREATED WITH INTEGRILIN AND 2MG OF T

  Patient problems: No Code Available; Stroke/CVA; Thromboembolism

  MAUDE report 8992476 ↗
• MalfunctionAug 26, 2019Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION FOR PULMONARY ARTERIOVENOUS MALFORMATION (AVM) AT THE PULMONAL ARTERY, A 11MM X 37CM MICRUSFRAME18 (MFR181137, L11609) WAS BEING USED AS THE FIRST FRAMING COIL. HOWEVER, THE CONCOMITANT MICROCATHETER WAS NOT STABLE AND THE COMPLAINT COIL DID NOT FIT IN THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO REMOVE THE COMPLAINT COIL, BUT THERE WAS A RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER. THE COIL GOT SPLIT AT THE HUB OF THE MICROCATHETER. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT¿S BODY. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER PRODUCT AND THE PROCEDURE COMPLETED SAFELY. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8931313 ↗
• MalfunctionDec 4, 2018Off-Label Use; Separation Failure; Off-Label Use; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN EMERGENT COIL EMBOLIZATION OF A SPLANCHNIC ARTERY ANEURYSM, THE 11MM X 37CM MICRUSFRAME 18 (MFR181137/S13144) THERMO-MECHANICAL COIL WAS SELECTED AS THE FIRST COIL WITH THE ENPOWER (ECB00018200/S14342) CONTROL CABLE, BUT AN ELECTRIC CONDUCTION FAILURE OCCURRED. THE COIL AND CONTROL CABLE WERE REPLACED, AND COMPETITOR COILS WERE PLACED IN THE ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. AN EXCELSIOR1018 (STRYKER) MICROCATHETER, AN ANGIO GUIDING CATHETER, AND AN ENPOWER DCB2000500 DETACHMENT CONTROL BOX WERE ALSO USED IN THE CASE. THE FIRST PHYSICIAN PREPPED THE PRODUCTS AND STARTED DELIVERY OF THE COILS. THE COMPLAINT COIL WAS CHOSEN AS THE FIRST COIL WITH THE COMPLAINT CABLE; HOWEVER, THE ELECTRIC CONDUCTION FAILURE OCCURR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8129249 ↗
• InjuryNov 13, 2018Off-Label Use; Premature Separation; Off-Label Use; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ISOLATED COMMON HEPATIC ARTERY ANEURYSM, THE 11MM X 37CM MICRUSFRAME18 (MFR181137/UNK LOT) THERMO-MECHANICAL COIL WAS INSERTED INTO THE PROGREAT (TERUMO) MICROCATHETER AND THE EMBOLIC COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE COIL WAS IMPLANTED BY FLUSHING THE MICROCATHETER. SOME PUSHABLE COILS WERE PLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. AN ENPOWER DCB2 DETACHMENT CONTROL BOX WAS ALSO USED IN THE CASE. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8067440 ↗
• MalfunctionJul 3, 2018Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN UNRUPTURED INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) ANEURYSM, THE 11MM X 37CM MICROFRAME 18 (MFR181137/S14769) THERMO-MECHANICAL COIL DELIVERY SYSTEM WAS INSERTED INTO THE ECHELON 10 (MEDTRONIC) MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AFTER 2-3 CENTIMETERS (CM). THE COIL DELIVERY SYSTEM GOT STUCK AND COULD NO LONGER BE ADVANCED THROUGH THE MICROCATHETER. THE MICROCATHETER WAS REPLACED WITH AN SL-10 (STRYKER) MICROCATHETER, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER COIL FROM THE SAME LOT. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. A DOUBLE-CATHETER TECHNIQUE WAS USED FOR THE PROCEDURE. A FUBUKI (ASAHI INTECC) GUIDING CATHETER, A MERIT MEDICAL Y-CONNECTOR, AND A DCB05 DETACHMENT CONTROL BOX WERE ALSO UTILIZED FOR THE CASE. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE COIL DELIVERY SYSTEM WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658006 ↗
• MalfunctionNov 20, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  DURING COIL EMBOLIZATION OF AN ANEURYSM FOR EVER, A MICRUSFRAME 18 (MFR181034/ C42047) BECAME STUCK IN THE PROWLER SELECT PLUS (606S255FX/17136614) AND THE COIL DETACHED, AND ANOTHER MICRUSFRAME 18 COIL (MFR181137/ S11770) ALSO BECAME STUCK IN THE MICROCATHETER. PRODUCT ANALYSIS FOUND THAT ONE COIL WAS RETURNED DETACHED AND THE OTHER COIL WAS RETURNED KINKED. WHEN THE COIL EMBOLIZATION WAS PERFORMED AT THE SUPERIOR GLUTEAL ARTERY, THE COMPLAINT COIL (LOT C42047) WAS USED WITH THE COMPLAINT CATHETER (PROWLER SELECT PLUS) BUT IT GOT STUCK IN THE CATHETER. THE PHYSICIAN TRIED TO REMOVE THE COIL, BUT IT WAS DETACHED IN THE CATHETER. THEREFORE, THE COIL WAS REMOVED WITH THE CATHETER. THE COIL AND THE CATHETER WERE REPLACED WITH ANOTHER ONE. THE MICRUSPHERE DID NOT APPEAR DAMAGED. THEN THE NEXT MICRUSFRAME COIL (LOT S11770) WAS ATTEMPTED TO BE USED, BUT IT GOT STUCK IN THE UNSPECIFIED MICROCATHETER AND WAS REPLACED WITH ANOTHER COIL. THE MICRUSPHERE DID NOT APPEAR DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY USING THE SAME MICROCATHETER. THE PATIENT WAS A MALE BUT HIS AGE WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047410 ↗