MICRUSFRAME MFR100730Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886704077886), received between Jun 8, 2018 and Nov 17, 2025 — classified as 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 17, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE MICRUSFRAME10 7MM X 30CM (MFR100730/ 31188535) COILS COULD NOT BE INTRODUCED INTO MICROCATHETER. MICROCATHETER WAS SAVED AND IS AVAILABLE FOR RETURN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER CNV COILS. NO PATIENT HARM. ADDITIONAL EVENT INFORMATION STATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE WAS CHECKED BEFORE INTRODUCTION INTO PATIENT, COIL COULD NOT BE PUSHED OUT OF INTRODUCER SHEATH BECAUSE RESISTANCE WAS FELT. A CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT, BUT COMPLAINT HAPPENED BEFORE INTRODUCTION INTO MICROCATHETER (MC). THEY COULD NOT BE PUSHED OUT OF INTRODUCER SHEATH TO BE INSPECTED BEFORE USE IN PATIENT. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS KINKED AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570333 ↗
• MalfunctionApr 3, 2024Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 7MM X 30CM MICRUSFRAME 10 COIL (MFR100730 / 30860270) ¿CANNOT ADVANCE THE [INTO] THE MICROCATHETER.¿ THE COIL WAS REPLACED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 02-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE EVENT DATE WAS 01-MAR-2024. THE PROCEDURE WAS TARGETING A PARACLINOID-INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE RESISTANCE WAS FIRST EXPERIENCED INSIDE THE INTRODUCER SHEATH, ¿BUT DON¿T KNOW WHICH PART OF THE INTRODUCER.¿ THE MICROCATHETER USED WAS A HEADWAY® 17 MICROCATHETER (MICROVENTION). PER THE INFORMATION, MORE THAN FIVE (5) GALAXY G3 AND GALAXY G3 MINI COILS WERE SUCCESSFULLY USED WITH THE HEADWAY 17 MICROCATHETER AFTER THE REPORTED RESISTANCE ISSUE OCCURRED AND ¿THEY ARE ALL GOOD.¿ THERE WAS NO ISSUE WITH THE MICROCATHETER, ¿THE CATHETER IS FINE.¿ THE REPORTED RESISTANCE ISSUE OCCURRED BEFORE THE 7MM X 30CM MICRUSFRAME 10 COIL (MFR100730 / 30860270) WAS INTRODUCED INTO THE VESSEL. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO PUSH THE COIL INTO THE MICROCATHETER, THE PHYSICIAN REMOVED THE COIL AND ¿IT SEEMS DEFORMED.¿ NOTHING W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038888 ↗
• MalfunctionMar 21, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 7MM X 30CM MICRUSFRAME 10 (MFR100730 / 30860270) CANNOT BE DETACHED. THE CONTROL CABLE AND DETACHMENT CONTROL BOX HAVE BEEN ELIMINATED. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 14-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET WAS A PARACLINOID INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED AND IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE CONCOMITANT MICROCATHETER USED WAS A HEADWAY® 17 MICROCATHETER (MICROVENTION); THE HEADWAY® 17 MICROCATHETER (MICROVENTION) WAS USED TO COMPLETE THE CASE. THE REPLACEMENT COIL WAS A 7MM X 21CM GALAXY G3 COIL. PER THE INFORMATION, A PRE-DEPLOYMENT CHECK WAS NOT PERFORMED, ¿BUT WE CHECKED THE ELECTRIC DEPLOYMENT AFTER THE COIL WAS REMOVED, AND EVERYTHING IS FINE EXCEPT COIL.¿ THE FAULT LIGHT WAS NOT SEEN DURING THE CASE. IT WAS UNKNOWN IF UPON PRESSING THE POWER BUTTON, ALL THE LIGHTS ILLUMINATED; IT WAS INDICATED THAT ¿THE ENPOWER WORKS FIND ON OT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956633 ↗
• MalfunctionMar 6, 2024Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A LARGE 8MM ANEURYSM LOCATED ON THE INTERNAL CAROTID ARTERY (ICA) JUST AFTER SYPHON / MEDIAL OF OPHTHALMIC ARTERY IN A YOUNG PATIENT WITH VERY TORTUOUS ANATOMY, THE ECHELON¿ 14 MICROCATHETER (MEDTRONIC) WAS PLACED INTO THE ANEURYSM BUT THE POSITION WAS NOT VERY STABLE DUE TO ANATOMY AND ANGLES, THE COILS WERE NOT DETACHABLE. THE FIRST COIL, A 7MM X 30CM MICRUSFRAME 10 (MFR100730 / 30860269) WAS CHECKED IN SALINE FOR CONFIGURATION AND CHECKED ELECTRICALLY; NO PROBLEMS WERE NOTED. THE COIL WAS PUSHED THROUGH THE MICROCATHETER WITH A LITTLE MORE RESISTANCE THAN USUALLY NOTED. THE COIL WAS THEN POSITIONED INTO THE TARGET ANEURYSM PERFECTLY. DETACHMENT DID NOT WORK. THE PHYSICIAN MADE 10 TO 12 UNSUCCESSFUL ATTEMPTS TO DETACH THE COIL. THE DETACHMENT CONTROL BOX AND THE CONTROL CABLES WERE EXCHANGED BUT THE COIL WAS STILL NOT DETACHABLE. THE BALLOON CATHETER (UNSPECIFIED BRAND) WAS INFLATED TO PROTECT AGAINST SMALL EMBOLIC COMING FROM THE ANEURYSM. THE COIL WAS REMOVED. DURING THE REMOVAL PROCESS, ELECTRIC SIGNAL WAS LOST AND AFTER COMPLETE REMOVAL, NO ELECTRICAL CONTACT WAS POSSIBLE. THE SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18853223 ↗
• MalfunctionFeb 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE INTRODUCER SHEATH OF THE 7MM X 30CM MICRUSFRAME 10 COIL (MFR100730 / 30649218) WAS RIPPED DURING THE PROCEDURE, AFTER RE-SHEATHING ONE TIME AND TRYING TO RE-INTRODUCE THE COIL INTO THE CONCOMITANT MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH A ¿COUPLE OF MINUTES¿ OF DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 07-FEB-2024, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. THIS MEETS US FDA REPORTING CRITERIA UNDER 21 CRF 803 AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664692 ↗
• MalfunctionSep 14, 2023Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 7MM X 30CM MICRUSFRAME 10 (MFR100730 / 30757481) GOT STUCK SEVERAL TIMES IN THE MICROCATHETER (UNSPECIFIED BRAND). THE COIL COULD NOT BE POSITIONED WITH STABILITY INSIDE THE FISTULA. IT WAS REPORTED THAT THE COIL ¿LOOKED SKEW.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750111 ↗
• MalfunctionJun 29, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TARGETING A BASILAR ANEURYSM, THE PHYSICIAN USED A 7MM X 14.3CM MICRUSFRAME 18 COIL (MFR180714 / 30362738) AS THE FIRST COIL. THE PHYSICIAN ATTEMPTED TO INSERT THE COIL THROUGH AN SL-10® MICROCATHETER (STRYKER) BUT IT DID NOT ADVANCE MORE THAN 20CM (NO FURTHER ADVANCEMENT OF THE DELIVERY WIRE AT THE POINT WHERE THE FLUORO MARKERS MET THE GREEN UNSHEATHING TOOL). THE PHYSICIAN REMOVED THIS COIL AND TRIED WITH TWO 7MM X 30CM MICRUSFRAME 10 COILS (MFR100730) FROM TWO DIFFERENT LOTS (K10620 AND K10276) WITH THE SAME RESULTS. THE PHYSICIAN PROCEEDED TO COMPLETE THE PROCEDURE WITH DIFFERENT COILS (A COMBINATION OF STRYKER AND PENUMBRA COILS) USING THE SAME CONCOMITANT SL-10® MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. THE REPORTED ISSUE RESULTED IN A 20-MINUTE PROCEDURE DELAY THAT WAS NOT DEEMED CLINICALLY SIGNIFICANT. ADDITIONAL INFORMATION INDICATED THAT THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE TIP OF THE INTRODUCERS WERE FLUSHED UNTIL LIQUID WAS VISIBLE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14855734 ↗
• MalfunctionNov 30, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A FISTULA COILING, A SL-10, STRYKER MICROCATHETER (MC) WAS USED. A MICRUSFRAME S10 WAS USED AS THE FIRST COIL, BUT IT WAS TOO SMALL. THE SECOND COIL WAS A MICRUSFRAME10 7MM X 30CM (MFR100730, LOT UNKNOWN) BUT IT COULD NOT BE PUSHED THROUGH THE MICROCATHETER. AFTERWARDS, AN ATTEMPT WAS MADE TO DEPLOY THE COIL OUTSIDE THE PATIENT IN A WATER BASIN, BUT THIS WAS ALSO NOT POSSIBLE. THE COIL COULD NOT BE PUSHED OUT OF THE INSERTION DEVICE. AFTERWARDS, ANOTHER COIL OF THE SAME SIZE WAS USED, WHICH COULD AGAIN BE PUSHED THROUGH THE SAME CATHETER NORMALLY. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NECESSARY TO REMOVE THE MICROCATHETER BECAUSE THE COIL COULD NOT BE PUSHED THROUGH. THE MC WAS CONTROLLED. CEREBRAL POSITION WAS ALSO LOST FOR A SHORT TIME. HOWEVER, THIS WAS NOT A MAJOR PROBLEM. THE MC WAS NOT DAMAGED DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE SAME CATHETER WAS STILL USED FOR THE INTERVENTION. THE COIL DELIVERY SYSTEM DID NOT APPEAR TO BE DAMAGED AT A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12893722 ↗
• MalfunctionNov 30, 2020Mechanical Problem; Mechanical Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 7MM X 30CM MICRUSFRAME10 COIL (MFR100730, L14312) DID NOT LOAD PROPERLY WHEN IN USE. THERE WAS RESISTANCE WHILE ADVANCING TO A POINT WHERE THEY WERE NO LONGER ABLE TO ADVANCE THE COIL AT ALL. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. ONLY THE COIL DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER COIL. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS NO SIGNIFICANT PROCEDURE PROLONGATION DUE TO THE EVENT. THERE WAS NO REPORT OF DEVICE PREPPING DIFFICULTY. THE COIL WAS NOT IMPLANTED. THERE WERE NO FRAGMENTS THAT REMAINED IN THE PATIENT. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10920751 ↗
• MalfunctionJun 8, 2018Kinked; Kinked

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT WHEN PLACING THE MICRUSFRAME 10 COIL (MFR100730/S12565) IN THE MICROCATHETER, THE SHEATH OF THE COIL TORE. IT WAS IMPOSSIBLE TO USE THE DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED. SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, BUT A RESPONSE HAS NOT BEEN RECEIVED. NOTE: THIS EVENT WAS DEEMED MDR REPORTABLE BASED ON THE DEVICE EVALUATION FINDINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7583220 ↗