MICRUSFRAME MFR181447Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886704078111), received between Feb 6, 2018 and Jan 17, 2024 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Stretched” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Positioning Failure; Material Split, Cut or Torn; Positioning Failure; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF SUBCLAVIAN ARTERY DURING A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR), A MICRUSFRAME18 14MM X 47CM COIL (MFR181447, 30692244) WAS INSERTED VIA THE FEMORAL APPROACH. DURING RETRIEVAL OF THE MICRUSFRAME18 FROM THE PATIENT¿S BODY, PEELER GOT DAMAGED AND COULD NOT RE-SHEATH THE COIL, SO REPLACED WITH ANOTHER NEW COIL. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. A PROWLER SELECT PLUS MICROCATHETER (MC) WAS USED. ADDITIONAL INFORMATION WAS RECEIVED ON 29-DEC-2023 INDICATING THAT COIL HERNIATION WAS LET TO THE RESHEATHING OF THE COIL. THERE WAS A SPLIT ON THE INTRODUCER. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE COIL THROUGH THE MC. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526096 ↗
• InjuryDec 13, 2023Premature Separation; Premature Separation

  IT WAS REPORTED, VIA A PERSONAL INTERACTION, THAT A MICRUSFRAME18 14MM X 47CM (MFR181447/ 30692244) WAS USED FOR A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ARTERY ANEURYSM. DURING THE PROCEDURE, THE USER REPORTED PREMATURE DETACHMENT OF THE COIL DURING PLACEMENT, EVEN THOUGH THE CONTROL CABLE WAS NOT ATTACHED TO THE CONNECTOR. A SNARE WAS USED TO RETRIEVE THE COIL AND THE SURGEON REPLACED THE PREMATURELY DETACHED COIL WITH A DIFFERENT, NEW COIL OF THE SAME SIZE. A TOTAL 28 COILS WERE USED DURING THE PROCEDURE, 8 OF WHICH WERE CERENOVUS COILS. THE 28 COILS WERE PLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT AS A RESULT OF THE EVENT. A CONTINUOUS FLUSH WAS NOT DONE. ANOTHER CONCOMITANT DEVICE USED WAS A ¿COILING SUPPORT MICROCATHETER, (B)(4) DETACHMENT DEVICE.¿ THE MICRUSFRAME18 HAS BEEN DISCARDED AND WILL NOT BE AVAILABLE FOR FURTHER PRODUCT INVESTIGATION. NO FURTHER INFORMATION WAS MADE AVAILABLE AT THE TIME OF THIS REVIEW. THE EVENT WAS REPORTED AS SUCH: ¿THE PROCEDURE WAS A COIL EMBOLIZATION OF RENAL ARTERY ANEURYSM. ATTEMPTED TO PLACE A TARGRTXXL (STRYKER) FOR FRAMING BUT WAS UNABLE TO FORM IT INTO A SHAPE, SO IT WAS RET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318397 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, THE 64-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CONTROLLED HYPERLIPIDEMIA, CONTROLLED HYPERTENSION, SMOKING (CURRENT), AND INTRACRANIAL ANEURYSMS (TOTAL OF 3) PRESENTED WITH A SUBARACHNOID HEMORRHAGE (SAH) SECONDARY TO RUPTURED ANEURYSM (HUNT & HESS GRADE 2) AND SUBSEQUENTLY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED ANEURYSM ON THE LEFT SIDEWALL OF THE INTERNAL CAROTID ARTERY (ICA): HEIGHT: 10MM, DOME: 12MM, MAXIMUM ANEURYSM DIAMETER: 17MM, NECK SIZE: 7.8MM, AND DOME-TO-NECK RATIO: 1.5MM. THE PARENT VESSEL DIAMETER WAS 5.8MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED PRE-PROCEDURE. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF THE FOLLOWING COILS: A 14MM X 47CM MICRUSFRAME18 COIL (MFR181447 / L10314), A 11MM X 37CM MICRUSFRAME18 COIL (MFR181137 / L10312), A 10MM X 30CM GALAXY G3 COIL (GLY121030 / L11083), AND A 9MM X 25CM GALAXY G3 COIL (GLY120925 / L10732) VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). AN 8MM X 24CM GALAXY G3 COIL (GLY120824 / L15747) WAS USED BUT NOT IMPLANTED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17857136 ↗
• MalfunctionFeb 14, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION FOR A 20MM ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA), AN ENTERPRISE II INTRACRANIAL STENT WAS IMPLANTED. A HYDRO COIL(S) WAS USED FOR FRAMING FROM A SL10 MICROCATHETER (MC). SEVERAL TARGET XL COILS WERE IMPLANTED AND A MICRUSFRAME18 16MM X 47CM COIL (MFR181647, (B)(4)) WAS USED BUT BECAME STUCK ON THE MICROCATHETER. THIS COIL WAS REPLACED WITH ANOTHER MICRUSFRAME18 14MM X 47CM COIL (MFR181447, (B)(4)) BUT BECAME STUCK DURING COILING AND UNRAVELED. THE UNRAVELED COMPLAINT COIL WAS REMOVED, AND COMPETITOR¿S COILS WERE USED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE A MICROCATHETER (EXSELSIOR SL10), A Y-CONNECTOR (TERUMO) AND AN INTERMEDIATE CATHETER (NAVIEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371639 ↗
• MalfunctionNov 8, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE WITH THE TARGET AT THE SPLENIC ARTERY, THE 14MM X 47CM MICRUSFRAME 18 COIL (MFR181447 / L16716) WAS USED AFTER SEVERAL COILS WERE USED. THE COMPLAINT COIL WAS INSERTED INTO THE MICROCATHETER AS THE SHEATH INTRODUCER WAS PRESSED AGAINST THE HUB OF THE MICROCATHETER (COILING SUPPORT), BUT THERE WAS AN INTENSE RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER. THE PHYSICIAN REMOVED THE COMPLAINT COIL AND NOTICED THAT IT HAD UNRAVELED. IT WAS REPLACED WITH ANOTHER SAME COIL OF THE SAME SIZE AND THE REPLACEMENT COIL WAS USED WITHOUT ANY ISSUE. THE COMPLAINT DOCUMENTED THAT IT WAS ¿UNCLEAR IF CONTINUOUS FLUSH WAS DONE.¿ THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT PRODUCT WAS REPORTED AS NOT AVAILABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771320 ↗
• MalfunctionAug 9, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 14MM X 47CM MICRUSFRAME 18 COIL (MFR181447 / 30362944) WAS USED AS THE FIRST AND ANCHORING COIL. IT WAS IMPLANTED AND THE PHYSICIAN ATTEMPTED TO DETACH IT BUT IT WAS NOT ABLE TO BE DETACHED. THE POWER LAMP DID NOT ILLUMINATE; THE CONNECTING CABLE (ECB00018200 / 30574599) WAS REPLACED BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND IT WAS USED WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED; THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297411 ↗
• MalfunctionMay 10, 2021Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 14MM X 47CM MICRUSFRAME 18 COIL (MFR181447 / L13938) BEING USED WITH THE CONCOMITANT HEADWAY® MICROCATHETER (MICROVENTION) DID NOT DETACH EVEN AFTER THE DETACHMENT CONTROL CABLE WAS REPLACED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802886 ↗
• InjuryApr 30, 2019Entrapment of Device; Entrapment of Device

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL-ASSISTED BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN THE GUIDEWIRE (UNSPECIFIED BRAND) WAS BEING ADVANCED THROUGH THE PROWLER SELECT LPES MICROCATHETER (606S155FX / 30122336). THE MICROCATHETER WAS REPLACED AND THERE WAS NO FURTHER ISSUE WITH RESISTANCE FELT. THE PHYSICIAN STARTED THE COIL EMBOLIZATION AND INSERTED THE 14MM X 47CM MICRUSFRAME 18 COIL (MFR181447 / S12293) AND RE-ROLLED SEVERAL TIMES TO RELEASE THE COIL; BUT THE COIL WAS SLIGHTLY CAUGHT AND PULLED OUT OF THE COIL MASS. THE GUIDEWIRE WAS USED TO PUSH THE COIL BACK INTO THE COIL MASS SEVERAL TIMES AND THE PROCEDURE WAS COMPLETED WITH THE COIL PLACED IN THE ANEURYSM. THE PHYSICIAN CHECKED THE TIP OF THE DELIVERY WIRE AFTER THE PROCEDURE WAS COMPLETED AND NOTED THAT THERE WAS AN ABNORMALITY IN THE HEATING PART. IT WAS REPORTED THAT PRIOR TO THE COMPLAINT COIL, OTHER COILS WERE ADVANCED THROUGH THE MICROCATHETER WITHOUT ANY ISSUE. THERE WAS NO DAMAGE ON THE COIL OR COIL DELIVERY SYSTEM PRIOR TO USE. THE GUIDEWIRE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO USE. THERE WAS NO REPORT OF ANY PATIENT

  Patient problems: No Code Available

  MAUDE report 8566144 ↗
• MalfunctionNov 20, 2018Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF THE PULMONARY ARTERIOVENOUS MALFORMATION (AVF) AT THE PULMONARY VEIN, THE MICROCATHETER (LIGHTHOUSE, PIOLAX) WAS INSERTED AND THE MICRUSFRAME 18 14MM X 47CM COIL (MFR181447 / L11607) WAS INSERTED INTO THE MICROCATHETER WHERE IT BECAME IMPEDED. THE COIL WAS REMOVED, AND IT UNRAVELED. IT WAS REPORTED THAT SUSTAINED, ADEQUATE FLUSH WAS MAINTAINED. 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 PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8093103 ↗
• MalfunctionFeb 6, 2018Kinked; Stretched; Kinked; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION FOR AN ENDOLEAK II PREVENTION AT THE LEFT INTERNAL ILIAC ARTERY, A MICRUSFRAME (MFR181447/ S13430) INTRODUCER SHEATH SPLIT OPEN AND THE COIL WAS EXPOSED AND DURING PRODUCT ANALYSIS ON (B)(6) 2018, IT WAS DETERMINED THAT THE EMBOLIC COIL WAS STRETCHED AND KINKED. IT WAS REPORTED THAT THE COMPLAINT PRODUCT WAS NOT FLUSHED DURING THE PROCEDURE. THE GUIDING CATHETER, MICROCATHETER, AND GUIDING WIRE WERE INSERTED TO INITIATE COIL EMBOLIZATION. THE DIAMETER OF THE LESION WAS 12 MM TO 13 MM. THE COMPLAINT COIL WAS CHOSEN AS THE FIRST COIL, AND PREPARATION WAS DONE AS PER IFU. THE PHYSICIAN INSERTED THE DELIVERY WIRE; HOWEVER, THE SHEATH SPLIT AND THE COIL WAS EXPOSED. THEREFORE, IT WAS REPLACED WITH A NEW COIL AND PREPARED AS PER IFU. TWO MORE COILS (13 MM*43 CM FRAMES, 10 MM*40 CM DELTAFILL) WERE IMPLANTED IN THE TARGET LESION. 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 A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7246124 ↗