MICRUSFRAME MFR140408Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704077985), received between Oct 16, 2017 and Dec 18, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MICRISFRAME14 4MM X 8CM (MFR140408/(B)(6)) KINKED DURING THE INTERVENTION CASE. THE PHYSICIAN USED ANOTHER COIL AND THE PROCEDURE DONE WELL. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347402 ↗
• InjurySep 20, 2022Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2022, DURING A PULSERIDER STENT-ASSISTED COIL EMBOLIZATION WITH THE TARGET ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA), A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) WAS DELIVERED TO THE TARGET REGION AND DEPLOYED. THE PHYSICIAN ATTEMPTED TO FRAME THE ANEURYSM BY USING A 4MM X 8CM MICRUSFRAME 14 COIL (MFR140408 / LOT# UNKNOWN). HOWEVER, THE COIL DID NOT FIT WELL, SO THE COIL WAS REMOVED FROM THE PATIENT¿S BODY. ON THE SECOND ATTEMPT, THE PHYSICIAN ATTEMPTED TO COMPLETE THE FRAMING BY CHANGING THE MICROCATHETER SHAPE AND THE COIL SIZE / TYPE WITH THE FOLLOWING COILS: A 3.5MM X 9CM GALAXY G3 XSFT (GLX123509 / LOT# UNKNOWN), A 3MM X 8CM HYDROSOFT® COIL (MICROVENTION-TERUMO), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / LOT# UNKNOWN). HOWEVER THESE COILS ALSO DID NOT FIT WELL SO THEY WERE REMOVED FROM THE PATIENT¿S BODY. IN ADDITION, THE PHYSICIAN ALSO NOTICED THAT THE DEPLOYED PULSERIDER ANRD DID NOT SUFFICIENTLY COVER THE ANEURYSM NECK, THEREFORE, THE PHYSICIAN ALSO REMOVED THE PULSERIDER ANRD. ON THE THIRD ATTEMPT, THE PHYSICIAN TRIED THE BALLOON-ASSIST TECHNIQUE. THE PHYSI

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15456492 ↗
• MalfunctionAug 30, 2021Separation Failure; Premature Separation; Separation Failure; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AND AFTER PLACING A 4MM X 8CM MICRUSFRAME 14 COIL (MFR140408, K10575) IN THE ANEURYSM, THE COIL DID NOT WANT TO DETACH WITH THE DETACHMENT SYSTEM. THEY TRIED TO DETACH IT WITH A DETACHMENT SYSTEM MORE THAN ONE TIME. THIS DID NOT WORK; THEY PULLED THE COIL BACK (OUT OF THE ANEURYSM), THE COIL DETACHED WHILE PULLING IT BACK. THEY HAD TO MANUALLY REMOVE THE COIL FROM THE HUB. THE COIL WAS USED IN COMBINATION WITH A HEADWAY 17 MICROCATHETER (MC172150SX), A SOFIA EX SUPPORT CATHETER (ISC5115ST) AND A FLEXOR 6FR 80CM SHEATH (G13539). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385915 ↗
• MalfunctionJun 27, 2019Separation Failure; Separation Failure

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF GASTROINTESTINAL HEMORRHAGE, THE PHYSICIAN ATTEMPTED TO CONFIRM THE ELECTRICAL CHECK, BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE WHEN USING THE 4MM X 8CM MICRUSFRAM14 COIL (MFR140408, S13016) AND THE ENPOWER CONTROL CABLE (ECB00018200, S14553). THEREFORE, THE COIL DELIVERY SYSTEM AND THE CABLE WERE REMOVED, AND THEY WERE REPLACED WITH OTHER PRODUCTS. THE PROCEDURE CONTINUED WITHOUT ANY PROBLEMS AND IT WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE FAILURE DID NOT OCCUR DURING PRE-DEPLOYMENT ELECTRICAL CHECK. THERE WAS NO DAMAGE TO THE DEVICES PRIOR TO USE. THE DEVICES WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739704 ↗
• MalfunctionDec 11, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE DUODENAL ARTERY, THE 4MM X 8CM MICRUSFRAME 14 COIL (MFR140408 / S13650) WAS INSERTED INTO THE MICROCATHETER (CARNELIAN SI, TOKAI MEDICAL PRODUCTS) AFTER THE MICROCATHETER REACHED THE TARGET LESION, HOWEVER, THE COIL WAS MET WITH RESISTANCE AND GOT STUCK 10 CM FROM THE TARGET LESION. THERE WAS NO ISSUE ENCOUNTERED WHEN THE COIL WAS BEING INSERTED INTO THE MICROCATHETER. THE COIL DID NOT KINK OR BEND OR MET ANY RESISTANCE / FRICTION PRIOR TO THE REPORTED EVENT OCCURRING. THE MICRUSFRAME 14 COIL WAS REPLACED WITH ANOTHER COIL (4MM X 8CM TARGET® COIL, STRYKER) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY USING THE SAME MICROCATHETER. 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 T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8152185 ↗
• MalfunctionJan 10, 2018Positioning Failure; Positioning Failure

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN ANEURYSM OF THE BRONCHIAL AND NON-BRONCHIAL (BAE) AT THE PULMONARY ARTERY, AFTER A COIL (DELTAFILL4X15) WAS DETACHED, THE MCRUSFRAME14(MFR140408, S13017) WAS INSERTED WITHOUT ANY RESISTANCE. THE COIL WAS CONNECTED TO THE CABLE AND ATTEMPTED TO DETACH BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN TRIED TO DETACH THE COIL SEVERAL TIMES, THE CABLE WAS REPLACED AND THE COIL WAS FLUSHED BUT THE ISSUE CONTINUED. THEREFORE, THE COIL WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE PRODUCT WILL BE RETURNED FOR THE INVESTIGATION. THE MICRUSFRAME14 COIL 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. IT WAS APPROXIMATELY 2 MM OF VESSEL EMBOLUS. 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. A GUIDEWIRE (SUCCEED), MICROCATHETER (1018) AND DCB02 WERE ALSO USED FOR THIS PROCEDURE. THE PA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7177891 ↗
• MalfunctionOct 16, 2017Stretched; Delivery System Failure; Stretched; Delivery System Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSFRAME14 (MFR140408/S12445) WAS USED DURING A COIL EMBOLIZATION PROCEDURE OF A CEREBRAL ANEURYSM WHEN THE COIL FAILED TO DETACH. THE MICRUSFRAME14 (COMPLAINT PRODUCT) WAS CONNECTED TO THE CABLE DURING PREPARATION, HOWEVER, THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AND THEREFORE THE COIL COULD NOT BE USED FOR THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT¿S INFORMATION, INCLUDING THE VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION, WERE UNKNOWN. NO REPORT OF OTHER DEVICES USED DURING THIS PROCEDURE IS AVAILABLE. 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 AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. THE PRODUCT WILL BE RETURNED FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6951770 ↗