MICRUSFRAME MFR140820Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704078029), received between Mar 1, 2019 and Dec 5, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2020Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-ENDOVASCULAR ANEURYSM REPAIR (EVAR) COIL EMBOLIZATION PROCEDURE WITH THE TARGET ANEURYSM LOCATED AT THE INTERNAL ILIAC ARTERY, A 5FR IMPRESS® DIAGNOSTIC CATHETER (MERIT MEDICAL) AND THE PROWLER SELECT PLUS MICROCATHETER WERE DELIVERED TO THE TARGET LESION. THE 8MM X 20CM MICRUSFRAME 14 COIL (MFR140820 / L12221) WAS THE THIRD COIL USED AFTER TWO OTHER CNV COILS WERE IMPLANTED. THE 20CM COIL CAME OUT OF THE MICROCATHETER AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. THE DELIVERY WIRE WAS SLOWLY RETRACTED BUT THE COIL DID NOT DETACH. THE PHYSICIAN TRIED AGAIN BUT THE SAME ISSUE OCCURRED. THE DETACHMENT LAMP ILLUMINATED, AND THE AUDIBLE SIGNAL WAS HEARD AS USUAL. THE POWER OF THE CONTROL CABLE WAS RESET, AND THE CABLE AND THE COIL WERE RECONNECTED, BUT THE SAME ISSUE CONTINUES. THE PHYSICIAN SUSPECTED THAT THE COIL MIGHT HAVE DETACHED, AND THE COIL WAS CAREFULLY RESHEATHED INTO THE MICROCATHETER. THE COIL BECAME DETACHED AT THE HUB DURING THE RESHEATHING ATTEMPT. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER 8MM X 20CM MICRUSFRAME 14 COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950218 ↗
• MalfunctionNov 7, 2019Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY, WHEN THE WIRE WAS ADVANCED WITH THE SHEATH HELD IN THE UNSPECIFIED MICROCATHETER (MC), THE SHEATH BECAME BROKEN. THE 8MM X 20CM MICRUSFRAME14 COIL (MFR140820, S14125) CAME OUT FROM THE SHEATH¿S GAP. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER PRODUCT. THE PROCEDURE COMPLETED SAFELY. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9289681 ↗
• MalfunctionJul 2, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A PULMONARY ARTERIOVENOUS FISTULA (AVF), A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED FOR THE 8MM X 20CM MICRUSFRAME 14 COIL (MFR140820 / S13415) AND THE ENPOWER CONTROL CABLE FOR THE MICROCOIL DELIVERY SYSTEM (ECB00018200 / S14553), BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. THE DEVICES WERE 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 DEVICES ARE NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8754881 ↗
• MalfunctionApr 1, 2019Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) AT THE PULMONARY VEIN, THE 8 MM X 20 CM MICRUSFRAME 14 COIL (MFR140820 / L12732) WAS DELIVERED TO THE TARGET LESION BUT THE COIL SIZE DID NOT FIT. WHEN THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, IT WAS REPORTED THAT THE COIL HAD BECOME UNRAVELED EVEN THOUGH IT WAS HANDLED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU). THE COIL WAS REPLACED; THE PROCEDURE WAS RESUMED TO SUCCESSFUL COMPLETION 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 PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469800 ↗
• MalfunctionMar 1, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A SPLANCHNIC ARTERY ANEURYSM AT THE RENAL ARTERY. THE TARGET LESION WAS REPORTED TO HAVE A WIDE NECK AND AS A RESULT, BECAME A BALLOON-ASSISTED COIL EMBOLIZATION PROCEDURE. THE MICROCATHETER (PIOLAX, LIGHTHOUSE) WAS DELIVERED TO THE LESION AND THE COIL EMBOLIZATION PROCEDURE WAS INITIATED. THE 8MM X 20CM MICRUSFRAME 14 COIL (MFR140820 / S13812) WAS ONE OF THE COILS USED AND IT WAS INSERTED INTO THE MICROCATHETER, BUT THERE WAS SOME RESISTANCE FELT IN THE SHEATH INTRODUCER AND THE COIL WAS REMOVED FROM THE PATIENT¿S BODY. IT WAS CONFIRMED THAT CONTINUOUS AND ADEQUATE FLUSH WAS MAINTAINED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY 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 CONTINUOUS FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. IT WAS REPORTED THAT THIS PROCEDURE WAS THE HOSPITAL¿S FIRST TIME USE OF THE SPECTRA COILS. THE 8MM X 20CM MICRUSFRA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8383332 ↗