MICRUSFRAME MFR140922Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704078036), received between Jan 5, 2018 and Jul 7, 2020 — classified as 1 injury, 2 malfunctions.

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE STERLING STUDY, A (B)(6) MALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES AND SMOKING (CURRENT) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2019 AND EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6) 2020 REQUIRING REPEAT COIL EMBOLIZATION ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RIGHT PCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.8MM, DOME 9.6MM, MAXIMUM ANEURYSM DIAMETER 9.6MM, NECK SIZE 5.0MM, AND DOME-TO-NECK RATIO 1.9MM. PARENT VESSEL DIAMETER WAS 2.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L13627), ONE 3.5MM X 9CM GALAXY G3 XSFT (GLX123509/L12045), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408/L13272), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L13817), ONE 5MM X 10CM GALAXY G3 (GLY120510/L13038), ONE 6MM X 11.9CM MICRUSFRAME10 (MFR100611/L15887), ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/L15266), ONE 9MM X 22CM MICRUSFRAME14 (MFR140922/L15601), ONE 2MM X 6CM GALAXY G3 XSFT HEL (GLX120206/L11700), AND ONE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208/L1

  Patient problems: No Code Available

  MAUDE report 10239884 ↗
• MalfunctionMar 18, 2019Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THE COIL EMBOLIZATION PROCEDURE TARGETING A CEREBRAL ANEURYSM AT THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) A STENT (LVIS®, MICROVENTION) WAS DEPLOYED AND THE COIL IMPLANTATION WAS INITIATED; FRAMING AND FILLING WERE DONE WITH COMPETITOR COILS. WHEN THE 9MM X 22CM MICRUSFRAME 14 COIL (MFR140922 / S11594) WAS INSERTED AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE ENPOWER CONTROL CABLE (ECB00018200 / L11277), THE COIL DID NOT DETACH. THE ENPOWER CONTROL CABLE AND THE DETACHMENT CONTROL BOX WERE REPLACED BUT THE COIL STILL FAILED TO DETACH. THE 9MM X 22CM MICRUSFRAME 14 COIL WAS REPLACED WITH ANOTHER COMPETITIVE COIL AND THE REPLACEMENT COIL WAS DETACHED. ADDITIONAL COILS WERE IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429665 ↗
• MalfunctionJan 5, 2018Positioning Failure; Premature Activation; Torn Material; Positioning Failure; Premature Activation; Torn Material

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM AT THE INTERNAL CAROTID CAVE (ICCAVE), A MICRUSFRAME14 (MFR140922, S13226) WAS INSERTED TO THE LESION AND WAS CONNECTED TO THE ENPOWERCONTROL CABLE (ECB000182-00, S13745) FOR DETACHMENT BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN TRIED TO DETACH THE COIL SEVERAL TIMES BUT THE ISSUE CONTINUED. THE CABLE WAS REPLACED BUT THE COIL COULD NOT BE DETACHED ALTHOUGH THE POWER LUMP ILLUMINATED. THE COIL WAS REMOVED AND IT WAS TEARED IN THE Y CONNECTION OF THE MICRO CATHETER. THE COIL IN THE Y CONNECTION WAS REMOVED AND THE COIL WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED FOR 5 MINUTES. THERE WAS NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE MICRUSFRAME COIL WILL BE RETURNED FOR INVESTIGATION. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND 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 VESSE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7167205 ↗