MICRUSFRAME MFR181647Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704078135), received between Feb 7, 2017 and Jul 16, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A SPLENIC ARTERY ANEURYSM, DEVICES WERE ALL USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). IT WAS REPORTED THAT AFTER THE APPROACH TO THE SPLENIC ARTERY ANEURYSM WAS MADE WITH THE PARENT PLUS 30® GUIDE SHEATH (MEDIKIT), 5F ANGIOGRAPHIC CATHETER (UNSPECIFIED BRAND), AND AN ECHELON® MICROCATHETER (MEDTRONIC), THE FIRST 16MM X 47CM MICRUSFRAME 18 (MFR181647 / 31168434) WAS INSERTED VIA THE ECHELON MICROCATHETER. DUE TO THE IRREGULAR SHAPE OF THE ANEURYSM, THE COILING WAS UNSUCCESSFUL, AND THE COIL WAS RETRIEVED AND RE-WINDED SEVERAL TIMES. THE PHYSICIAN FELT INCREASED RESISTANCE INSIDE THE MICROCATHETER EACH TIME THE COIL WAS INSERTED AND REMOVED. DURING THE INSERTION AND REMOVAL, THE SHEATH WAS DAMAGED, SO THE COIL WAS REPLACED WITH A SECOND 16MM X 47CM MICRUSFRAME 18 (MFR181647 / 31168434). SIMILAR TO THE FIRST 16MM X 47CM MICRUSFRAME 18 COIL, THE SECOND COIL ALSO GRADUALLY ENCOUNTERED INCREASED RESISTANCE INSIDE THE MICROCATHETER, AND ULTIMATELY, UPON RETRIEVAL OF THE COIL, AN UNRAVELING WAS CONFIRMED, LEADING TO THE DECISION TO ABANDON ITS USE. DUE TO A SHORTAGE OF STOCK IN 16MM X

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521781 ↗
• MalfunctionJan 13, 2021Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 16MM X 47CM MICRUSFRAME18 COIL (MFR181647, K10015) WAS ATTEMPTED TO COME OUT FROM THE TIP OF A CONCOMITANT MICROCATHETER (1.9FR CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS) BUT THE MICROCATHETER KICKED BACK. THE PHYSICIAN ATTEMPTED TO RETRACT THE COMPLAINT COIL BUT IT DETACHED. THE TIP OF THE COMPLAINT COIL WAS INSIDE THE MICROCATHETER (MC) THEREFORE, THE COIL WAS REMOVED WITH THE MICROCATHETER TOGETHER. THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER (SAME CATALOG NUMBER/ DIFFERENT LOT NUMBER) AND THE COMPLAINT COIL WAS REPLACED WITH A COMPETITIVE COIL AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO EXCESSIVE FORCE USED WITH TRYING TO RETRACT THE MICRUSFRAME18 16MM X 47CM. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS NO SIGNIFICANT PROLONGATION IN THE PROCEDURE DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11163252 ↗
• MalfunctionAug 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AT THE SPLENIC ARTERY THROMBUS, A 16MM X 47CM MICRUSFRAME18 COIL (MFR181647, S12393) WAS ATTEMPTED TO BE USED AS THE FRAMING. THE PHYSICIAN WINDED WITH THE COMPLAINT COIL ONCE, HOWEVER THE DELIVERY WIRE COULD NOT ADVANCE. THE COMPLAINT COIL WAS ATTEMPTED TO BE RE-SHEATHED, BUT IT COULD NOT. THEN, THE COMPLAINT COIL WAS DETACHED ALTHOUGH THE DETACH BUTTON WAS NOT PRESSED AND THE COMPLAINT COIL PRE-MATURELY DETACHED IN THE MICROCATHETER DURING WITHDRAW. THEREFORE, THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT¿S BODY TOGETHER WITH THE CONCOMITANT MICROCATHETER. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER THE 16MM X 50CM DELTAFILL18 COIL AND IT WAS USED AS THE FRAMING COIL. THERE WAS A SLIGHT RESISTANCE FELT BETWEEN THE COIL AND THE MICROCATHETER, BUT THE COIL WAS IMPLANTED TO THE TARGET LESION SAFELY. AFTER THAT, THE FOLLOWING COILS WERE IMPLANTED: A 10MM X 50CM INTERLOCK COIL, 8MM X 35CM DELTAFILL18 COIL, 10MM X 50CM INTERLOCK COIL, 5MM X 20CM DELTAFILL18 COIL, AND A 6MM X 25CM DELTAFILL18 COIL. EXCESSIVE FORCE WAS APPLIED TO THE DEVICES. ADEQUATE FLUSH HAD NOT BEEN MAINTAINED THROUGH THE DEVICES. NO COIL DEVICE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865560 ↗
• MalfunctionJun 12, 2019Stretched; Stretched

  AS REPORTED BY AN AFFILIATE, DURING A PRE-STENT GRAFT COIL EMBOLIZATION OF AN ANEURYSM AT THE LEFT INTERNAL ILIAC ARTERY, A MICRUSFRAME18 S COIL (MFR181647, L10828) WAS BEING USED AS A SECOND COIL, HOWEVER, THERE WAS RESISTANCE FELT BETWEEN THE INTRODUCER SHEATH AND THE COIL DURING DELIVERY AND IT COULD NOT BE DELIVERED. THE COIL WAS RE-SHEATHED ONCE, AND WAS INSERTED AGAIN, BUT THE ISSUE CONTINUED. THEREFORE, IT WAS REPLACED WITH ANOTHER COIL (MFR181647). THREE IDC COILS AND THREE SPECTRA COILS WERE IMPLANTED AFTERWARDS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. THERE WAS NO EXCESSIVE FORCE USED AT ANY TIME. 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. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8693095 ↗
• MalfunctionSep 19, 2018Unraveled Material; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A BALLOON-ASSISTED COIL EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, THE 16MM X 47CM MICRUSFRAME18 (MFR181647/L10828) THERMO-MECHANICAL COIL WAS BEING PLACED IN THE ANEURYSM AS THE FIRST COIL IN THE CASE, BUT THE COIL MOVED DUE TO RAPID BLOOD FLOW IN THE PARENT ARTERY AND THE COIL BECAME UNRAVELED. THE COIL AND THE STRYKER MICROCATHETER WERE REMOVED AS A UNIT AND THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A COOK SHEATH INTRODUCER, ASAHI GUIDEWIRE, COOK GUIDING CATHETER, STRYKER BALLOON CATHETER, AND AN ENPOWER DCB2 DETACHMENT CONTROL BOX WERE ALSO UTILIZED FOR THE CASE. THE PRODUCT WAS DISCARDED AND IS THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889723 ↗
• MalfunctionFeb 7, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A MICRUSFRAME COIL (MFR181647/ S11433) STRETCHED DURING COILING OF A LARGE ANTERIOR COMMUNICATING ARTERY AV FISTULA. THE MICRUSFRAME WAS DEPLOYED AS AN INITIAL FRAMING COIL THROUGH THE ECHELON 10 MICROCATHETER; HOWEVER, THE PHYSICIAN DETERMINED THAT IT WAS UNDERSIZED AND NEEDED TO BE RE-SHEATH THE COIL. WHEN IMMEDIATELY WITHDRAWING THE COIL VIA THE PUSHER WIRE, THE PHYSICIAN NOTICED THE ABSENCE OF A ONE TO ONE FEEL OF THE COIL PUSHER WIRE. WHEN THEY CHECKED UNDER FLUOROSCOPY, IT WAS CONFIRMED THAT THE COILS WAS STRETCHING; HOWEVER, THE CAUSE OF THE STRETCHING COULD NOT BE DETERMINED. THE PHYSICIAN THEN RE-ADVANCED THE COIL INTO THE FISTULA AND PROPER PLACEMENT WAS THEN ACHIEVED. HE CONTINUED TO DETACH THE COIL WITH NO OTHER ISSUES. THERE WAS NO PATIENT INJURY, INTERRUPTION OF ARTERIAL BLOOD FLOW OR DELAY IN THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER, AND THERE WAS NO RESISTANCE BETWEEN THE COIL AND MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL COILS TO OCCLUDE THE FISTULA. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6307173 ↗