MICRUSFRAME MFR100517Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704077831), received between Sep 1, 2017 and Aug 9, 2023 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2023Failure to Advance; Failure to Advance

  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 17495452 ↗
• MalfunctionAug 9, 2023Failure to Advance; Failure to Advance

  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 17495451 ↗
• MalfunctionAug 9, 2023Failure to Advance; Failure to Advance

  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 17495450 ↗
• MalfunctionAug 9, 2023Failure to Advance; Failure to Advance

  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 17495449 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (SUBJECT (B)(6)), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830, 30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, L16774), MICRUSFRAME10 5MM X 17CM (MFR100517, 30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, K10010), GALAXY G3 XSFT 4MM X 10CM (GLX120410, K10380), MICRUSFRAME14 12MM X 30CM (MFR141230, L15281), GALAXY G3 XSFT 3MM X 6CM (GLX120306, L16504), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.5

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987179 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (SUBJECT (B)(6)), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830,30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, L16774), MICRUSFRAME10 5MM X 17CM (MFR100517,30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, K10010), GALAXY G3 XSFT 4MM X 10CM (GLX120410, K10380), MICRUSFRAME14 12MM X 30CM (MFR141230, L15281), GALAXY G3 XSFT 3MM X 6CM (GLX120306, L16504), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.5MM

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987097 ↗
• MalfunctionMay 21, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED VIA THE (B)(6) 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 17CM MICRUSFRAME 10 COIL (MFR100517 / L11196) 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 17CM 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 WAS D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628926 ↗
• MalfunctionMay 2, 2019Material Separation; Stretched; Material Separation; Stretched

  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 17CM MICRUSFRAME 10 COIL (MFR100517 / L11654) WAS ONE OF THE COILS USED. THERE WAS NO REPORT OF COIL POSITIONING DIFFICULTY; THE COIL DID NOT HAVE ANY DIFFICULTY CONFORMING TO THE ANEURYSM WALL. WHEN THE COIL WAS 2/3 INSIDE THE ANEURYSM, THE PHYSICIAN FELT RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER AND ATTEMPTED TO RETRACT THE MICROCATHETER SLIPPED OUT OF THE ANEURYSM. THE MICROCATHETER WAS PUSHED BACK OVER THE COIL INTO THE ANEURYSM, NO RESISTANCE WAS FELT, AND THE COIL WAS DETACHED BUT NOT AT THE POINT OF DETACHMENT. IT WAS REPORTED THAT NO FORCE WAS APPLIED BUT THE COIL SEPARATED INTO TWO WITH HALF OF THE COIL IN THE ANEURYSM WHICH WAS PUSHED INTO THE ANEURYSM; THE COIL DID NOT PROTRUDE INTO THE PARENT VESSEL. THE OTHER PROXIMAL HALF OF THE COIL WAS REMOVED FROM THE PATIENT. IT WAS CONFIRMED THAT THERE WAS NO COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS; AS THERE WERE NO PREVIOUSLY PLACED COILS. NO ADDITIONAL INTERVENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575911 ↗
• MalfunctionDec 13, 2017Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION FOR AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH SUBARACHNOID HEMORRHAGE, A MICRUSFRAME10 ((B)(4)) COULD NOT EXIT THE INTRODUCER SHEATH, AND DURING PRODUCT ANALYSIS, IT WAS FOUND THAT THE COIL WAS KINKED. THE SHEATH WAS INSERTED INTO THE Y CONNECTOR. AFTER FLUSHING, THE MICRUSFRAME10 (COMPLAINT PRODUCT) WAS ATTEMPTED TO BE INSERTED, BUT THE COIL DID NOT COME OUT FROM THE SHEATH, SO THE COIL WAS REMOVED FROM. ABOUT 10 CENTIMETERS OF COIL CAME OUT FROM THE TIP OF THE SHEATH, BUT COIL WAS NOT ADVANCED AT ALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7112822 ↗
• MalfunctionSep 19, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSFRAME10 COIL (MFR100517/S11573) WAS USED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR A PEDIATRIC VV SHUNT WHERE THE COIL COULD NOT BE DETACHED. THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED WITH THE MICRUSFRAME10 (COMPLAINT PRODUCT) BUT THE LAMP DID NOT BLINK WHEN IT WAS CONNECTED TO THE CONTROL BOX. THE COIL WAS REPLACED WITH ANOTHER MICRUSFRAME10 COIL (SAME CATALOG NUMBER). THE PATIENT WAS A (B)(6) FEMALE WHOSE VESSEL WAS MODERATELY TORTUOUS, CALCIFICATION WAS UNKNOWN. A GUIDING CATHETER (MEDIKIT) AND A MICROCATHETER (EXCELSIOR1018, STRYKER) WERE ALSO USED FOR THIS PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE ISSUE OCCURRED DURING THE PRE-DEPLOYMENT ELECTRICAL CHECK. THE PRODUCT WILL BE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6875077 ↗
• MalfunctionSep 1, 2017Sticking; Failure to Advance; Material Protrusion/Extrusion

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY ANEURYSM (C2) A MICRUSFRAME 10 COIL (MFR100517/ S12171) PROTRUDED INTO THE PARENT VESSEL AND THE COIL COULD NOT BE RE-SHEATHED DUE TO SHEATH DAMAGE, AND ANOTHER MICRUSFRAME 10 COIL (MFR100517/ S12171) COULD NOT BE INSERTED THROUGH THE MICROCATHETER HUB. THE MICROCATHETER WAS APPROACHED TO THE LESION AND THE MICURSFRAME10 (COMPLAINT PRODUCT) WAS STUCK IN THE SL 10 MICROCATHETER HUB AND COULD NOT BE ADVANCED. THE COIL WAS USED FOR FRAMING, BUT THE COIL COME OUT TO THE PARENT VESSEL, SO A TRANSFORM BALLOON WAS INFLATED. AT THE TIME, THE BALLOON SLIPPED, AND COME OUT WITH THE MICROCATHETER. THE PHYSICIAN TRIED TO RE-SHEATH THE COIL, BUT THE SHEATH INTRODUCER BECAME DAMAGED AND THE DEVICE COULD NOT BE USED AT ALL. THE MICROCATHETER WAS CHANGED TO THE ANOTHER ONE (90°SHAPE) AND IT WAS REINSERTED INTO THE LESION. THE COIL WAS REPLACED WITH ANOTHER MICRUSFRAME 10 (SECOND COMPLAINT PRODUCT) AND THEY ATTEMPTED TO INSERT IT INTO THE MICROCATHETER, BUT IT GOT STUCK AT THE HUB AND COULD NOT BE ADVANCE. IT WAS FLUSHED IN THE Y CONNECTOR AND THEY ATTEMPTED TO REINSERT, BUT THE COIL COULD NOT BE INSERT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6838243 ↗
• MalfunctionSep 1, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A 5MM RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH SUBARACHNOID HEMORRHAGE, A MICRUSFRAME 10 COIL (MFR100517/ S13059) COULD NOT BE DETACHED USING TWO ENPOWER CONTROL CABLES (ECB00018200/ S13060 AND ECB00018-00/ P11151). THE MICRUSFRAME 10 WAS SELECTED FOR THE FIRST COIL AND PRE-DETACHMENT CHECK WAS PERFORMED. AFTER CREATING THE FRAME IN THE ANEURYSM, THE COIL WAS ATTEMPTED TO BE DETACHED, SO THE PHYSICIAN CONNECTED IT TO THE CONNECTOR, BUT THE POWER LIGHT OF THE CONTROL BOX DID NOT ILLUMINATE. THE CABLE WAS REPLACED WITH ANOTHER ONE, BUT THE ISSUE CONTINUED. THE DETACHMENT BUTTON WAS PRESSED WHILE USING BOTH CABLES, BUT THERE WAS NO RESPONSE. THE COIL WAS REMOVED WITHOUT ANY PROBLEM. THE COIL WAS REPLACED WITH ANOTHER ONE. COMPETITORS COILS WERE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED FOR 10 MINUTES. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6837662 ↗