MICRUSFRAME MFR181950Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704078166), received between Feb 20, 2018 and Jun 13, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Kinked” (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.

• MalfunctionJun 13, 2019Separation Failure; Separation Failure

  AS REPORTED BY AN AFFILIATE, A MICRUSFRAME18 COIL (MFR181950, S13071) FULLY DEPLOYED BUT DID NOT DETACH. THERE WERE NO PATIENT CONSEQUENCES. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT BY FIVE MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SYSTEM PRIOR TO USE. THERE WAS AN ADEQUATE CONTINUOUS FLUSH MAINTAINED THROUGH THE CATHETER. THE DEPLOYMENT ISSUE WAS NOT RELATED TO DIFFICULTY POSITIONING THE COIL IN THE ANEURYSM. THERE WAS NO DIFFICULTY GETTING THE COIL TO CONFORM TO THE ANEURYSM WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695259 ↗
• MalfunctionMay 30, 2018Kinked; Kinked

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A PULMONARY ARTERIOVENOUS MALFORMATION, STRONG RESISTANCE WAS FELT WHEN THE MICRUSFRAME18 19 MM X 50 CM (B)(4) WAS INSERTED INTO THE LEONIS MOVA MICROCATHETER SUMITOMO BAKELITE). IT WAS CONFIRMED THAT THE SHEATH INTRODUCER WAS DAMAGED AND THE COIL WAS EXPOSED FROM THE DAMAGED SHEATH. THE COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATIONS. 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. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. A GUIDING CATHETER (SELECON MP CATHETER, TERUMO CLINICAL SUPPLY), MICRO CATHETER (LEONIS MOVA, SUMITOMO BAKELITE) AND A DCB2 CONTROL BOX WERE ALSO USED FOR THIS PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7555446 ↗
• MalfunctionFeb 20, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOLEAK COIL EMBOLIZATION OF THE AORTIC ARCH, A 19 MM X 50 CM MICRUSFRAME THERMO-MECHANICAL COIL (MFR181950/S12902) WAS INSERTED INTO A PROGREAT 3 (TERUMO) MICROCATHETER AND THE PHYSICIAN ATTEMPTED SEVERAL TIMES TO DECIDE THE POSITION, BUT THE MICROCATHETER CAME OUT FROM THE VESSEL NEAR THE TARGET ANEURYSM. THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COIL WITHOUT SUCCESS. THE COIL WAS REPLACED WITHOUT DIFFICULTY. FOLLOWING PLACEMENT OF SEVERAL COILS IN THE FALSE LUMEN, A 20 MM X 60 CM DELTAFILL18 THERMO-MECHANICAL MICROCOIL (DLF182060/S13440) WAS INSERTED INTO THE Y-CONNECTOR BUT COULD NOT BE INSERTED INTO THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RE-INSERT THE COIL; HOWEVER, STRONG RESISTANCE WAS FELT AND THE COIL COULD ¿BARELY¿ BE INSERTED INTO THE MICROCATHETER. FURTHER CLARIFICATION RECEIVED INDICATED THAT THE RESISTANCE WAS ENCOUNTERED WITH THE INTRODUCER. ONLY THE DISTAL END OF THE EMBOLIC COIL ADVANCED OUT OF THE END OF THE INTRODUCER. THE COIL WAS SUBSEQUENTLY REPLACED WITH NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THE EVENT DID NOT RESULT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7282508 ↗