MICRUSFRAME MFR140717Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886704078012), received between Nov 11, 2019 and Mar 6, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2024Separation Failure; Premature Separation; Separation Failure; Premature Separation

  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 18853229 ↗
• MalfunctionMay 4, 2022Break; Positioning Problem; Break; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) COIL EMBOLIZATION PROCEDURE AT THE INFERIOR MESENTERIC ARTERY (IMA), A CONCOMITANT PROWLER SELECT PLUS MICROCATHETER WAS INDUCED TO THE TARGET LESION AFTER THE PARENT CATHETER WAS INTRODUCED INTO THE IMA. THEN THE 7MM X 17CM MICRUSFRAME 14 COIL (MFR140717 / 30362732) WAS USED. THE PHYSICIAN ATTEMPTED TO MAKE A FRAME BUT THE MICRUSFRAME WAS NOT ABLE TO MAKE THE SHAPE AS THE PHYSICIAN INTENDED. THE MICRUSFRAME WAS RESHEATHED. THEN THE 8MM X 35CM DELTAFILL 18 COIL (DLF180835 / 30464336) WAS USED, BUT IT WAS ALSO RESHEATHED BECAUSE IT WAS NOT ABLE TO MAKE THE SHAPE AS THE PHYSICIAN INTENDED. THE SIZE OF THE COIL WAS CHANGED WITH A SMALLER COIL AND OTHER COILS WERE USED AND THE FRAMING WAS SUCCESSFULLY COMPLETED. AFTER THE SUCCESSFUL FRAMING, THE RESHEATHED 7MM X 17CM MICRUSFRAME 14 AND 8MM X 35CM DELTAFILL 18 WERE USED, BUT THEY WERE REMOVED FROM THE PATIENT¿S BODY BECAUSE THE SHEATHS ON THESE COILS WERE DAMAGED AND NOT ABLE TO BE GUIDED. COIL EMBOLIZATION WAS PERFORMED WITH OTHER COILS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION. CONTINUOUS FLUSH W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274526 ↗
• MalfunctionOct 12, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR THE RIGHT INTERNAL ILIAC ARTERY ANEURYSM, A CONCOMITANT MICROCATHETER, LEONISMOVA, SUMITOMO BAKELITE AND A MICROCATHETER, CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS WERE APPROACHED TO THE RIGHT SUPERIOR GLUTEAL ARTERY. A MICRUSFRAME14 7MM X 17CM COIL (MFR140717, 30375954) WAS USED AS THE FIRST COIL. THE TOTAL LENGTH OF THE COMPLAINT COIL CAME OUT OF THE MICROCATHETER WITHOUT ANY PROBLEM. THE DETACHMENT CYCLE WAS DONE AND THE DELIVERY WIRE WAS SLOWLY PULLED, HOWEVER, THE COMPLAINT COIL WAS NOT DETACHED. EVEN WHEN THE DETACHING OPERATION WAS PERFORMED AGAIN, THE COMPLAINT COIL WAS NOT DETACHED AS IN THE FIRST CHALLENGE. THE CONTROLLER BOX WAS TURNED ON AND OFF AGAIN. HOWEVER, THE DETACHMENT FAILURE CONTINUED. IT WAS CONFIRMED THE UPPER GREEN POWER LIGHT WAS ILLUMINATED DURING NORMAL OPERATION. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME LOT AND THE REPLACEMENT COIL WAS DETACHED. AN ENPOWER CONTROL CABLE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12614893 ↗
• MalfunctionNov 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 7MM X 17CM MICRUSFRAME14 COIL (MFR140717, L12061) WAS BEING USED AS A THIRD COIL, HOWEVER, TRIED IT SEVERAL TIMES, BUT IT WAS NOT ¿DETAILED¿. THERE WAS NO PATIENT INJURY REPORTED. A PICTURE OF THE DEVICE WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304935 ↗