MICRUSFRAME MFR181846Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704078159), received between Mar 13, 2018 and Jun 27, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A BRONCHIAL ARTERY ANEURYSM, EMBOLIZATION WAS STARTED FROM THE DISTAL VESSEL AND SEVERAL COILS WERE PLANNED TO BE PLACED IN THE ANEURYSM. A 20MM X 50CM MICRUSFRAME 18 COIL (MFR182050 / 30878399) WAS USED, BUT RESISTANCE WAS FELT INSIDE THE CONCOMITANT MICROCATHETER, A LEONIS MOVA MICROCATHETER (SUMIMOTO BAKELITE) AND WAS WITHDRAWN. THE MICROCATHETER WAS REPLACED AND ANOTHER 20MM X 50CM MICRUSFRAME 18 COIL (MFR182050 / 30810153) WAS USED, BUT RESISTANCE WAS FELT AND THE COIL WAS RETRIEVED; THE COIL WAS THEN RE-INSERTED BUT THE RESISTANCE REMAINED AND THE COIL WAS RETRIEVED. IT WAS REPLACED WITH SMALLER SIZE COIL, A 18MM X 46CM MICRUSFRAME 18 COIL (MFR181846) AND IT WAS IMPLANTED WITHOUT ANY ISSUE. A SECOND 18MM X 46CM MICRUSFRAME 18 COIL (MFR181846 / 30797268) WAS ATTEMPTED TO BE PLACED, BUT THIS SECOND 18MM X 46CM MICRUSFRAME 18 COIL COULD NOT BE DETACHED. ANOTHER ATTEMPT TO DETACH WAS UNSUCCESSFUL AND THE COIL WAS RETRIEVED. IT WAS REPORTED THAT THE TREATMENT FACILITY DID NOT HAVE ANY ADDITIONAL 18MM X 46CM MICRUSFRAME 18 COIL, THEREFORE, A DELTA COIL (UNSPECIFIED SIZE) WAS USED AND THE PROC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213693 ↗
• MalfunctionMar 2, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A RENAL ARTERY ANEURYSM, A MICRUSFRAME18 18MM X 46CM COIL ( MFR181846, 30393172) WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU) BUT BECAME STUCK ON A MICROCATHETER. THE PHYSICIAN USED SOME FORCE FOR DELIVERING THE COMPLAINT COIL, BUT IT BECAME UNRAVELED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAS BEEN STABLE. A CONTINUOUS FLUSH WAS DONE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466858 ↗
• MalfunctionSep 7, 2022Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION AT THE LUNG SHUNT WITH A BREAKTHROUGH, BOSTON SCIENTIFIC MICROCATHETER (MC). THE FIRST UNSPECIFIED COIL WAS IMPLANTED AT THE ANEURYSM SAC AND THE COMPLAINT COIL, A 18MM X 46CM MICRUSFRAME18 WAS USED AS THE SECOND COIL. HOWEVER, THE MICRUSFRAME COIL WAS UNRAVELED. NO Y-CONNECTOR WAS USED. THE COMPLAINT COIL WAS BEING INSERTED BUT IT WAS DIFFICULT TO PLACE INSIDE THE MICROCATHETER. THE COMPLAINT COIL WAS RE-SHEATHED SEVERAL TIMES. WHEN RE-SHEATHING THE COMPLAINT COIL, THERE WAS A SENSE OF CUT. THE COMPLAINT COIL WAS UNRAVELED. THE COMPLAINT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER AND THERE WAS NO REMAINING. THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE. THE LESION WAS THE PULMONARY ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369352 ↗
• MalfunctionMar 13, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING BALLOON-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM, THERE WAS RESISTANCE ENCOUNTERED IN THE INTRODUCER OF TWO 18 MM X 46 CM MICRUSFRAME18 (MFR181846/ S12935) AND A 12 MM X 42 CM DELTAFILL18 (DLF181242/S13148) AND THE WIRE PROTRUDED THROUGH THE SHEATHS. APPROACH WAS MADE FROM THE RIGHT CVV WITH AN 8F 50 CM UNSPECIFIED SHEATH INTRODUCER. THE SHEATH INTRODUCER AND THE CONTRAST CATHETER WITH BALLOON WERE INSERTED AND APPROACHED TO THE RIGHT RV. THE PROWLER SELECT PLUS MICROCATHETER WAS ADVANCED TO THE TARGET LESION AND THE COIL EMBOLIZATION WAS INITIATED. THE FIRST MICRUSFRAME18 THERMO-MECHANICAL COIL WAS PLACED AND THE PRODUCT WAS INSERTED INTO THE MICROCATHETER, BUT ¿THE COIL COULD NOT BE INSERTED AT THE INTRODUCER.¿ THE DELIVERY WIRE WAS PUSHED REPEATEDLY, THEN THE DELIVERY WIRE CAME OUT FROM THE INTRODUCER. THE COIL WAS REPLACED WITH ANOTHER MICRUSFRAME18 BUT THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED WITH A DIFFERENT-SIZED COIL. IN THE MIDDLE OF THE PROCEDURE, THE SAME ISSUE OCCURRED WITH THE DELTAFILL18 THERMO-MECHANICAL COIL AND THE COIL WAS SUBSEQUENTLY REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7336572 ↗
• MalfunctionMar 13, 2018Kinked; Stretched; Kinked; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING BALLOON-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM, THERE WAS RESISTANCE ENCOUNTERED IN THE INTRODUCER OF TWO 18MM X 46CM MICRUSFRAME 18 (MFR181846/ S12935) AND A 12MM X 42CM DELTAFILL18 (DLF181242/S13148) AND THE WIRE PROTRUDED THROUGH THE SHEATHS. APPROACH WAS MADE FROM THE RIGHT CVV WITH AN 8F 50CM UNSPECIFIED SHEATH INTRODUCER. THE SHEATH INTRODUCER AND THE CONTRAST CATHETER WITH BALLOON WERE INSERTED AND APPROACHED TO THE RIGHT RV. THE PROWLER SELECT PLUS MICROCATHETER WAS ADVANCED TO THE TARGET LESION AND THE COIL EMBOLIZATION WAS INITIATED. THE FIRST MICRUSFRAME 18 THERMO-MECHANICAL COIL WAS PLACED AND THE PRODUCT WAS INSERTED INTO THE MICROCATHETER, BUT ¿THE COIL COULD NOT BE INSERTED AT THE INTRODUCER.¿ THE DELIVERY WIRE WAS PUSHED REPEATEDLY, THEN THE DELIVERY WIRE CAME OUT FROM THE INTRODUCER. THE COIL WAS REPLACED WITH ANOTHER MICRUSFRAME 18 18 BUT THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED WITH A DIFFERENT-SIZED COIL. IN THE MIDDLE OF THE PROCEDURE, THE SAME ISSUE OCCURRED WITH THE DELTAFILL 18 THERMO-MECHANICAL COIL AND THE COIL WAS SUBSEQUENTLY REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7336564 ↗