MICRUSFRAME MFR140512Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886704077992), received between Dec 21, 2017 and Apr 18, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (3 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.

• MalfunctionApr 18, 2022Break; Defective Device; Break; Defective Device

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 5MMX12CM MICRUSFRAME14 COIL (MFR140512, 30390738) WAS USED IN A CASE OF INTRA-ANEURYSMAL PACKING OF THE CELIAC ARTERY ANEURYSM. WHEN THE COMPLAINT COIL WAS BEING DELIVERED USING A 160CM MARVEL MICROCATHETER (MC) AND A Y-CONNECTOR. THE TOTAL LENGTH INCLUDING THE DELIVERY WIRE WAS NOT ENOUGH AND THE SHEATH DID NOT COME OUT EVEN WHEN THE USER TRIED TO PULL OUT THE SHEATH. IT WAS ALSO REPORTED THAT THE LENGTH WAS SHORT WHEN HE PUSHED THE CABLE CONNECTIONS, ETC., AND THE DEVICE GOT DAMAGED WHEN THEY WERE RETRIEVED. THERE WAS NO PATIENT INJURY REPORTED. ANOTHER COIL WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS CONTINUED TO BE USED DESPITE OF COIL LENGTH WAS TOO SHORT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT THE NEED FOR ADDITIONAL INTERVENTION. IT WAS NOT NECESSARY TO REMOVE THE CONCOMITANT DEVICES WITH THE COMPLAINT DEVICE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136577 ↗
• MalfunctionFeb 25, 2022Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET ON THE INFERIOR MESENTERIC ARTERY, THE 5MM X 12CM MICRUSFRAME 14 COIL (MFR140512/ L16894) WAS INSERTED BUT THE SIZE OF THE COIL DID NOT FIT THE TARGET LESION. THE COMPLAINT DEVICE WAS RESHEATHED BUT THE SHEATH BECAME SEPARATED, THEREFORE, IT COULD NOT BE RESHEATHED. CONTINUOUS FLUSH WAS MAINTAINED IN THE CONCOMITANT MICROCATHETER, A 1.7FR CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL). IT WAS REPLACED WITH ANOTHER CERENOVUS COIL AND THE PROCEDURE WAS CONTINUED. THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO PATIENT ADVERSE EVENT OR PATIENT COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 25-FEB-2022, THE EMBOLIC COIL WAS OBSERVED STRETCHED UNDER MICROSCOPIC INSPECTION. THIS EVENT HAS BEEN DEEMED FDA MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606638 ↗
• MalfunctionApr 28, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 5MM X 12CM MICRUSFRAME 14 COIL (MFR140512 / L14999) WAS THE FIRST COIL USED IN THE PROCEDURE; IT WAS REPORTED THAT THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 5MM X 12CM MICRUSFRAME 14 COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10006293 ↗
• MalfunctionMar 2, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 5MM X 12CM MICRUSFRAME14 COIL (MFR140512, L14999) WAS BEING USED AS A FILLING COIL, HOWEVER THE PHYSICIAN DID NOT LIKE THE SHAPE OF COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RE-SHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9773938 ↗
• MalfunctionFeb 26, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING A TYPE II ENDOLEAK WITH SEVERE VESSEL TORTUOSITY, THE 5MM X 12CM MICRUSFRAME 14 COIL (MFR140512 / S13723) WAS INSERTED INTO THE 0.0165-INCH CARRY LEON MICROCATHETER (UTM), BUT THERE WAS STRONG RESISTANCE FELT INSIDE THE MICROCATHETER. THIS ISSUE PRECLUDED COIL DELIVERY AND PLACEMENT. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL, A GALAXY G3 COIL; THE REPLACEMENT COIL WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED WITH THE GALAXY G3 COIL. THERE WERE NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED PROTRUDING FROM THE INTRODUCER AND IN KINKED CONDITION. BASED ON THE PRODUCT ANALYSIS 2/26/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759592 ↗
• MalfunctionJun 12, 2019Separation Failure; Separation Failure

  AS REPORTED BY AN AFFILIATE, WHEN USING A MFR140512 COIL (MFR140512, L14136) AS THE FIRST COIL AND A DELTAXSFT10 (DLX100306, L14759) AS A THIRD COIL, DETACH FAILURE WAS ENCOUNTERED WHILE DETACHING BOTH COILS. WHEN THE PHYSICIAN TRIED TO DETACH THE COIL WITH AN ENPOWER CONTROL CABLE (ECB00018200, L14798), THE BEEPING SOUND WAS NORMAL (CONNECTION LIGHT WAS ALSO OK). BUT DURING RETRIEVING DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEM. THE ENPOWER DETACHABLE CONTROL BOX (DCB2000500, L12008) AND THE CONNECTING CABLE WERE CHANGED TO NEW ONES. BUT THE CHANGED ONES ALSO SHOWED DETACH FAILURES. BOTH COILS WERE BARELY DETACHED AFTER 5~7 TIMES OF DETACH TRIALS. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT BY 20~25 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE TWO ENPOWER DETACHABLE CONTROL BOXES AND ONE CONTROL CABLE IS AVAILABLE FOR ANALYSIS. ONE CONTROL CABLE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692497 ↗
• MalfunctionMay 21, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED VIA THE (B)(6) STUDY DURING THE ENDOVASCULAR COILING PROCEDURE TARGETING A CHALLENGING WIDE-NECKED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM WITH INCORPORATION OF BOTH M2 BRANCHES, AFTER THE SUPERIOR M2 BRANCH WAS STENTED, THE 5MM X 12CM MICRUSFRAME 14 COIL (MFR140512 / S11586) WAS ONE OF THE COILS THAT WAS OPENED, INSERTED, AND DEPLOYED IN THE ANEURYSM BUT WAS NOT DETACHED. PER THE PHYSICIAN, INITIAL COIL PLACEMENT IS CRITICAL IN THESE CASES AS THE FRAMING COIL MUST BE POSITIONED JUST RIGHT TO ENSURE THAT THE UNPROTECTED M2 (INFERIOR BRANCH) DOES NOT BECOME OVERLY IMPINGED ON BY COIL. THE PHYSICIAN WAS NOT SATISFIED WITH HOW THE 5MM X 12CM MICRUSFRAME 14 COIL CONFORMED TO THE ANEURYSM WALL AND REMOVED THE COIL FROM THE PATIENT. THE COIL WAS NOT USED; THERE WAS NO DAMAGE TO THE COIL OR COIL INTRODUCER WHEN IT WAS REMOVED FROM THE PATIENT. PER THE PHYSICIAN, THIS INITIAL FRAMING COIL PLACEMENT WAS A TRIAL AND ERROR APPROACH AND IS THUS, NOT INDICATIVE OF ANY COIL DEFECT. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT; THE REPORTED EVENT DID RESULT IN A 5-MINUTE PROCEDURAL DELAY THAT WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628940 ↗
• MalfunctionApr 25, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 5MM X 12CM MICRUSFRAME 14 COIL (MFR140512 / S14765) IS ONE OF THREE COILS THAT WERE REPORTED AS NOT BEING ABLE TO ADVANCE THROUGH THE HUB OF THE SL-10® MICROCATHETER (STRYKER). THE MICRUSFRAME COIL WAS REMOVED AND THERE WAS NO OBSERVED DAMAGE ON THE COIL. IT WAS CONFIRMED THAT ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO KINK OR BEND ON THE COIL; THE MICROCATHETER WAS ALSO NOT KINKED NOR HAVE ANY BEND ON IT; THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE USING COMPETITOR¿S COILS. THERE WAS NO REPORT OF LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO REPORT OF PATIENT ADVERSE EVENT OR SIGNIFICANT PROCEDURAL DELAY ASSOCIATED WITH THE REPORTED EVENT. THE PRODUCTS WERE RETURNED FOR EVALUATION WHICH REVEALED THAT THE 5MM X 12CM MICRUSFRAME 14 COIL WAS IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 4/23/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8552828 ↗
• MalfunctionApr 26, 2018Kinked; Stretched; Kinked; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, THE 5 MM X 12 CM MICRUSFRAME14 (MFR140512/S13591) THERMO-MECHANICAL COIL WAS INSERTED INTO THE TARGET LESION; HOWEVER, THE SIZE OF THE COIL WAS DEEMED TOO LONG FOR THE LESION AND IT KICKED BACK FROM THE LESION. THEREFORE, THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COIL BUT THE SHEATH SPLIT OPEN WHEN THE RESHEATHING TOOL WAS PULLED BACK TOWARD THE END OF THE SHEATH. THE COIL WAS REPLACED WITH A MICRUSFRAME C COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S VESSEL WAS NEITHER TORTUOUS NOR CALCIFIED. A DCB02 DETACHMENT CONTROL BOX AND A PROWLER SELECT PLUS MICROCATHETER WERE ALSO USED FOR THE CASE. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SIZE OF THE COIL WAS CONSIDERED TOO B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7463869 ↗
• MalfunctionDec 21, 2017Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A BRONCHIAL ARTERY ANEURYSM, THE INTRODUCER OF A MICRUSFRAME14 (MFR140512/ S13050) WAS INSERTED INTO THE MICROCATHETER AND IT WAS DELIVERED, BUT THE DISTAL PORTION OF THE SHEATH OF RE-SHEATH TOOL WAS SPLIT OPEN AND THE DELIVERY WIRE EXPOSED. IT WAS DIFFICULT TO ADVANCE AND THE PHYSICIAN TRIED TO DELIVER, BUT IT GOT KINKED. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER ONE. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE PATIENT¿S VESSEL WAS NOT TORTUROUS AND NOT CALCIFIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE 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 VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RETURNED FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138199 ↗