MICRUSFRAME MFR180813Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704078050), received between Oct 18, 2022 and Jan 17, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE STERLING STUDY, A 54-YEAR-OLD FEMALE (SUBJECT (B)(6) WITH NO TARGETED MEDICAL HISTORY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2022. THE PATIENT¿S BASELINE MODIFIED RANKIN SCALE SCORE WAS 0 AND THE HUNT & HESS GRADE WAS 2 - MODERATE TO SEVERE HEADACHE, NUCHAL RIGIDITY, AND NO NEUROLOGIC DEFICIT OTHER THAN CRANIAL NERVE PALSY. THE DIMENSIONS OF THE ANTERIOR CEREBRAL ARTERY ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT OF 8.5 MM, DOME 8.1 MM, MAXIMUM ANEURYSM DIAMETER OF 8.1 MM, NECK SIZE OF 2.6 MM, AND THE DOME-TO-NECK RATIO OF 3.1 MM. THE PARENT VESSEL DIAMETER WAS 1.7 MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH FOUR (4) CERENOVUS COILS VIA AN SL-10 MICROCATHETER (STRYKER). THE COILS WERE THE FOLLOWING: ONE 8MM X 13.6MM MICRUSFRAME S (MFR180813/K10699), ONE 6 MM X 15 CM GALAXY G3 (GLY120615/K10390), ONE 4 MM X 12 CM GALAXY G3 (GLY120412/30637578), AND ONE GALAXY G3 XTRASOFT (GLX120306/30603573). HEPARIN WAS ADMINISTERED. THE SUBJECT DID NOT EXPERIENCE INTRA-OPERATIVE RUPTURE OR THROMBOEMBOLIC EVENTS. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COM

  Patient problems: Aneurysm

  MAUDE report 16187039 ↗
• MalfunctionOct 18, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY AN 8MM X 13.6CM MICRUSFRAME 18 COIL (MFR180813 / K10699), BUT THE COIL WOULD NOT DETACH. MULTIPLE ATTEMPTS WERE MADE AND THE STAFF BELIEVES THAT THE ENPOWER DETACHMENT CONTROL BOX (DCB2000500) IS NOT FUNCTIONING CORRECTLY. THE PHYSICIAN HAD TO REMOVE THE COIL FROM THE PATIENT AND SWITCHED TO STRYKER COILS. THERE WAS NO DELAY REPORTED. THE COMPLAINT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE REPLACEMENT STRYKER COIL WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT OUTCOME AS A RESULT OF THE REPORTED ISSUE. ON 06-OCT-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL EMBOLIZATION PROCEDURE WAS TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. A PRE-DEPLOYMENT CHECK WAS PERFORMED. THE FAULT LIGHT WAS NOT SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL THE LIGHTS DID ILLUMINATE AND THE GREEN SYSTEM READY LIGHT DID ILLUMINATE. IT WAS NOT KNOWN IF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625932 ↗