MICRUSFRAME MFR140306Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886704077961), received between Oct 8, 2018 and Nov 30, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, DURING THE RESHEATHING OF A 3MM X 6CM MICRUSFRAME 14 (MFR140306 / 30483237) AND A 6MM X 15CM MICRUSFRAME 14 (MFR140615 / 30571106), THE INTRODUCER COMPONENT IN EACH OF THE COIL FAILED TO BE REZIPPED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. TWO (2) PHOTOS WERE INCLUDED IN THE COMPLAINT OF THE TWO COMPLAINT PRODUCTS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. BASED ON THE RESULT OF THE PRODUCT ANALYSIS ASSOCIATED WITH THE 3MM X 6CM MICRUSFRAME 14 (MFR140306 / 30483237), THE REPORTED ISSUE HAS BEEN DETERMINED TO MEET REPORTING CRITERIA AS A "MALFUNCTION.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890799 ↗
• MalfunctionNov 18, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE 3MM X 6CM MICRUSFRAME 14 COIL (MFR140306 / L17147) FAILED TO BE RE-SHEATHED. NO FURTHER INFORMATION RELATED TO THE PROCEDURE OR TO THE DEVICE ISSUE IS AVAILABLE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON (B)(6) 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12837126 ↗
• MalfunctionApr 6, 2021Break; Failure to Advance; Break; Failure to Advance

  AS REPORTED BY THE FIELD, DURING EMERGENT COIL EMBOLIZATION OF A RUPTURED ANEURYSM AT THE RENAL ARTERY, A 3MM X 6CM MICRUSFRAME14 COIL (MFR140306, L16959) WAS USED BUT THE SHEATH GOT DAMAGED. IT WAS REPLACED WITH ANOTHER SAME SIZED COIL (SAME CATALOG NUMBER) AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE COMPLAINT COIL WAS USED BUT IT GOT STUCK AND THE SHEATH GOT DAMAGED. AN UNSPECIFIED CONCOMITANT MICROCATHETER (INNER 0.017 INCHES) WAS USED. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS NOTED AS BEING STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620040 ↗
• MalfunctionNov 10, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 3MM X 6CM MICRUSFRAME 14 COIL (MFR140306 / L14591) WAS IMPLANTED, AND READY TO BE DETACHED. HOWEVER, WHEN THE DETACHMENT BUTTON WAS PRESSED SEVERAL TIMES, THE COIL DID NOT DETACH. THE PHYSICIAN DID NOT REPLACE THE ENPOWER CONTROL CABLE, OR THE DETACHMENT CONTROL BOX; ONLY THE COIL WAS REMOVED AND REPLACED. THE NEW REPLACEMENT COIL DETACHED WITHOUT ANY ISSUE. THE PROCEDURE WAS RESUMED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10820210 ↗
• MalfunctionJul 29, 2020Unraveled Material; Positioning Problem; Unraveled Material; Positioning Problem

  AS REPORTED BY THE FIELD, DURING AN INTRACEREBRAL COIL EMBOLIZATION OF THE POSTERIOR CEREBRAL ARTERY RIGHT (BIFURCATION 6X4.5MM ANEURYSM), WHEN USING A 3MM X 6CM MICRUSFRAME14 COIL (MFR140306, L16488) AS THE SECOND COIL, THE COIL PROTRUDED INTO THE VESSEL AND THE PRESHAPED PROWLER14 45TIP MICROCATHETER (606151FX, 30148965) WAS DISLOCATED. THE COIL WAS RESHEATHED BUT BECAME STRETCHED INSIDE THE COIL SHEATH. THE MICROCATHETER WAS REMOVED TOGETHER WITH THE COIL. THE PROWLER14 WAS REMOVED BECAUSE IT WAS NOT POSSIBLE TO COMPLETELY RESHEATH THE MICRUSFRAME14. THE COIL WAS DISCARDED AND THE PROWLER 14 MICROCATHETER WAS CHECKED AND REGARDED AS OKAY, NO ISSUES. THE MICROCATHETER (MC) WAS USED FOR THE REMAINING OF THE PROCEDURE WITH TWO ADDITIONAL COILS. THERE WAS NO REPORT OF PATIENT INJURY. THERE WAS NO RESISTANCE/FRICTION BETWEEN THE COIL AND THE MC PRIOR TO THE STRETCHING. PRIOR TO THIS COIL, OTHER COILS HAD BEEN ADVANCED THROUGH THE SAME MICROCATHETER. THE COIL OF THE MICRUSFRAME14 WAS STILL ATTACHED TO THE DELIVERY WIRE WHEN REMOVED FROM THE PATIENT. THE DEVICE DID NOT PREMATURELY DETACH. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICES. THE DEVICE WAS REMOVED FROM THE PATIENT WITHO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338095 ↗
• MalfunctionJul 2, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE FOR A HEMORRHAGE, A PRE-DEPLOYMENT ELECTRICAL CHECK WAS ATTEMPTED WITH THE 3MM X 6CM MICRUSFRAME 14 COIL (MFR140306 / S12248), BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. THE DEVICE WAS REPLACED, AND THE PROCEDURE CONTINUED TO COMPLETION WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8754880 ↗
• MalfunctionApr 25, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 3MM X 6CM MICRUSFRAME 14 COIL (MFR140306 / S14060) 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 3MM X 6CM MICRUSFRAME 14 COIL WAS KINKED AND 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 8552829 ↗
• MalfunctionFeb 25, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE NEUROVASCULAR PROCEDURE, THE ENPOWER DETACHMENT CONTROL BOX HAD TO BE USED A TOTAL OF 11 TIMES BEFORE THE 3 MM X 6 CM MICRUSFRAME 14 COIL (MFR140306 / L13546) WAS DETACHED. THE PHYSICIAN STATED THAT HE HAD TO ¿RIP OFF¿ THE COIL TO GET IT TO DETACH AND IMPLANTED. THE REPORTED ISSUE WITH THE DETACHMENT RESULTED IN A 5-MINUTE PROCEDURAL DELAY AND THE PATIENT WAS EXPOSED TO APPROXIMATELY 2 ADDITIONAL MINUTES OF X-RAY EXPOSURE. IT WAS CONFIRMED THAT THE DETACHMENT CONTROL BOX WAS WORKING PROPERLY, IT SUCCESSFULLY WORKED WITH SUBSEQUENT COILS AFTER THE REPORTED EVENT WITHOUT ISSUES. THE LOW BATTERY AND FAULT LIGHTS WERE NOT SEEN DURING THE CASE; ALL CONNECTIONS FIT PROPERLY WITHOUT THE APPLICATION OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE AND DETACHMENT CONTROL BOX WERE USED WITH SUBSEQUENT COILS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATION OR ADVERSE EVENT. THE MICRUSFRAME 14 COIL WAS IMPLANTED AND IS THUS, NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367193 ↗
• MalfunctionFeb 22, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE SPLENIC ARTERY, WHEN THE 3MM X 6CM MICRUSFRAME 14 COIL (MFR140306 / L10718) WAS BEING ADVANCED INTO THE MICROCATHETER (UNKNOWN BRAND), THE DELIVERY WIRE AND THE COIL WERE CONFIRMED TO BE PROTRUDING FROM THE MIDDLE PORTION OF THE SHEATH INTRODUCER. AS A RESULT, THE MICRUSFRAME 14 COIL COULD NOT ADVANCE AND WAS REPLACED WITH A COMPETITOR COIL OF SIMILAR SIZE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. IT WAS CONFIRMED THAT THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THERE WAS NO ISSUE ENCOUNTERED DURING THE UNSHEATHING OF THE INTRODUCER TUBE FROM THE DELIVERY TUBE OF THE DETACHABLE COIL SYSTEM. NO EXCESSIVE FORCE WAS APPLIED AT ANY TIME. WHEN THE COIL WAS REMOVED FROM THE PATIENT FOR REPLACEMENT, IT WAS STILL ATTACHED TO DELIVERY SYSTEM. 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 O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362179 ↗
• MalfunctionJan 28, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE SPLENIC ARTERY, THE FIRST COIL USED WAS THE 3 MM X 6 CM MICRUSFRAME 14 COIL (MFR140306 / L12296). DURING THE ATTEMPT TO DETACH THE COIL, THE BUTTON ON THE ENPOWER CONTROL CABLE (ECB00018200 / S14674) WAS PRESSED ABOUT THREE TIMES, BUT THE COIL DID NOT DETACH. THE COIL WAS REPLACED WITH ANOTHER 3 MM X 6 CM MICRUSFRAME 14 COIL, BUT THE SAME ISSUE WITH THE COIL FAILING TO DETACH OCCURRED. THE ISSUE WAS RESOLVED WHEN THE ENPOWER CONTROL CABLE WAS REPLACED; THE REPLACEMENT COIL SUCCESSFULLY DETACHED WITH THE NEW ENPOWER CONTROL CABLE. 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 NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS REPORTED THAT THE 3 MM X 6 CM MICRUSFRAME 14 COIL IS NOT AVAILABLE TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8282371 ↗
• MalfunctionNov 19, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-TUMORECTOMY COIL EMBOLIZATION AT THE LEFT GASTRIC ARTERY, THE MICRUSFRAME 14 3MM X 6CM COIL (MFR140306 / L12067) WAS USED. THE GREEN SYSTEM READY LIGHT WAS CONFIRMED TO BE ON AND THE PHYSICIAN PRESSED THE DETACHMENT BUTTON, BUT THE COIL DID NOT DETACH. THE PHYSICIAN CHECKED THE DETACHMENT POSITION AND PRESSED THE BUTTON AGAIN, BUT THE COIL FAILED TO DETACH. THE BUTTON ON THE DETACHMENT CONTROL DEVICE WAS PRESSED FIVE TIMES AND COIL DETACHMENT WAS UNSUCCESSFUL. THE COIL WAS REMOVED FROM THE PATIENT¿S BODY AND REPLACED WITH ANOTHER COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY AFTER THE MICRUSFRAME 14 COIL WAS REPLACED. 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 NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WAS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086951 ↗
• MalfunctionOct 8, 2018Unraveled Material; Difficult or Delayed Separation; Unraveled Material; Difficult or Delayed Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE MICRUSFRAME 14 3MM X 6CM COIL (MFR140306 / L12015) WAS USED AS THE FIRST COIL, BUT THE COIL HAD ISSUE WITH DETACHMENT; WHEN THE COIL WAS DETACHED, IT DID NOT DETACH AT THE MARKER BUT INSTEAD AT THE CROSS WHERE THE MIDDLE OF THE DETACHABLE MARKER AND THE TWO MARKERS OVERLAP. THE TAIL OF THE COIL CAME OUT WHILE THE DELIVERY WIRE WAS REMOVED; IT WAS NOT KNOWN IF THE COIL TAIL BECAME UNRAVELED. THE DELIVERY WIRE WAS PUSHED, AND THE COIL WAS PLACED INTO THE LESION AND DETACHED AGAIN. AFTER THIS ISSUE, A G3 COIL WAS USED TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE REPORTED ISSUE DID NOT RESULT IN ANY PATIENT INJURY OR COMPLICATION; IT DID NOT CAUSE ANY CLINICAL DELAY IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A G3 COIL. 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 T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944855 ↗