MICRUSFRAME MFR140615Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704078005), received between Mar 22, 2018 and Jun 8, 2022 — classified as 1 injury, 4 malfunctions.

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

• MalfunctionJun 8, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, ACCESS WAS MADE WITH USING CONCOMITANT MICROCATHETER (CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS). WHEN THE PHYSICIAN ATTEMPTED TO DETACH AFTER WINDING THE 6MM X 15CM MICRUSFRAME COIL (MFR140615, 30498380), IT WAS NOT ABLE TO BE DETACHED NO MATTER HOW MANY TIMES THE PHYSICIAN PRESSED THE BUTTON. THE 6MM X 15CM MICRUSFRAME COIL AND THE EMPOWER CONTROL CABLE WERE REMOVED FROM THE PATIENT¿S BODY. AFTER THAT, THE CABLE WAS REPLACED WITH ANOTHER ONE. A NEW COIL OF ANOTHER LOT WAS USED, AND DETACHMENT WAS ACHIEVED. THEN, A 7MM X 17CM MICRUSFAME COIL (MFR140717, 30375954) WAS RE-SHEATHED TO ADJUST THE POSITION OF THE CATHETER, AND THEN COILING WAS ATTEMPTED AGAIN. HOWEVER, THE SHEATH WAS DAMAGED, AND DELIVERY WAS NOT POSSIBLE. THEREFORE, IT WAS REMOVED FROM THE PATIENT¿S BODY. THERE WAS NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS DONE. THE LESION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633008 ↗
• InjuryJul 27, 2021Separation Failure; Premature Separation; Separation Failure; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF A GASTRODUODENAL ARTERY PSEUDOANEURYSM, A 6MM X 15CM MICRUSFRAME14 (MFR140615/L16163) WAS SELECTED FOR USE AS THE FINAL COIL AND ATTEMPTED TO BE DETACHED, BUT THE COIL FAILED TO DETACH DESPITE USUAL ILLUMINATION OF THE POWER ¿LUMP¿. THE CONCOMITANT CARRY LEON (UTM) MICROCATHETER WAS PUSHED BACK AND FORTH AND ENERGIZATION WAS PERFORMED AGAIN BUT THE SAME ISSUE CONTINUED. THE OPERATOR ATTEMPTED TO REMOVE THE COIL FROM THE PATIENT, BUT THE COIL UNINTENDEDLY DETACHED AND MIGRATED TO THE ¿NORMAL BLOOD VESSELS NEAR THE PSEUDOANEURYSM¿. THE COIL WAS REMOVED FROM THE PATIENT USING A SOUTENIR (ASAHI INTECC) MICROSNARE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY. A TOTAL OF NINE COILS (INCLUDING J&J) WERE IMPLANTED PRIOR TO THIS COMPLAINT COIL. IT WAS REPORTED THAT THE COIL WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231495 ↗
• MalfunctionJun 5, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED VIA THE STERLING STUDY THAT DURING THE ENDOVASCULAR COIL EMBOLIZATION TARGETING A RIGHT BIFURCATED ANEURYSM ON THE POSTERIOR CEREBRAL ARTERY (PCA) WITH THE FOLLOWING DIMENSION: 6.5 MM HEIGHT, 3.8 MM DOME, 1.9 MM NECK, A MAXIMUM DIAMETER OF 6.5 MM, A DERIVED DOME TO NECK RATIO OF 2.0 MM, AND PARENT VESSEL DIAMETER OF 2.5MM, THE 6MM X 15CM MICRUSFRAME 14 COIL (MFR140615 / S14089) DELIVERED TO THE TARGET SITE VIA THE HEADWAY® 17 ADVANCED MICROCATHETER (MICROVENTION), BUT THE COIL DID NOT CONFORM TO THE ANEURYSM SHAPE AND WAS NOT IMPLANTED. IT WAS REPORTED THAT THE ANEURYSM WAS IRREGULARLY SHAPED, AND THIS MAY HAVE CONTRIBUTED TO THE REPORTED COIL CONFORMABILITY ISSUE. THE MICRUSFRAME COIL WAS NOT ABLE TO CONFORM TO THE ANEURYSM WALL, THERE WAS NO REPORT OF POSITIONING DIFFICULTY WHEN THE COIL WAS DELIVERED TO THE TARGET LESION; THE IRREGULAR SHAPE OF THE ANEURYSM DID NOT AFFECT THE POSITIONING OF THE COIL IN THE ANEURYSM. THE COIL WAS NOT DEPLOYED IN AN UNINTENDED SITE THAT IS PROXIMAL OR DISTAL TO THE TARGET LESION. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. IT WAS REPORTED THAT THE DEVICE WAS DISCARDED AND NOT AVAILABLE TO B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672908 ↗
• MalfunctionJun 14, 2018Difficult To Position; Premature Activation; Positioning Problem; Difficult To Position; Premature Activation; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A VERTICALLY LONG ANEURYSM AT THE DISTAL PORTION OF THE ANTERIOR CEREBRAL ARTERY (ACA), THE MICRUSFRAME14 6 MM X 15 CM (MFR140615 / S13658) WAS USED THE PHYSICIAN ATTEMPTED TO PLACE THE COIL IN THE ANEURYSM BUT EXPERIENCED POSITIONING DIFFICULTY AS THE COIL HERNIATED IN AND OUT OF THE LESION. IT WAS DETERMINED THAT THE COIL WAS OVERSIZE FOR THE LESION. THE COIL PREMATURELY DETACHED IN THE MICROCATHETER (STRYKER, SL-10) DURING THE RETRIEVAL ATTEMPT EVEN THOUGH CURRENT WAS NOT APPLIED. THE MICRUSFRAME14 COIL REMAINED IN THE MICROCATHETER AND AS A RESULT, BOTH THE COIL AND THE MICROCATHETER WERE REMOVED USING A FOREIGN BODY REMOVAL CATHETER FOR VESSELS (COVIDIEN, GOOSE NECK SNARE). THE MICRUSFRAME14 COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602254 ↗
• MalfunctionMar 22, 2018Unraveled Material; Unraveled Material

  A REPORT WAS RECEIVED THAT DURING A COIL EMBOLIZATION OF A GASTRODUODENAL ARTERY ANEURYSM (MFR140615/S13217), THE 6 MM X 15 CM MICRUSFRAME14 THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM WAS INSERTED INTO THE PROWLER LPES MICROCATHETER, BUT RESISTANCE WAS FELT AT 5 CENTIMETERS (CM). THE COIL WAS UNRAVELED WHEN REMOVED FROM THE MICROCATHETER. THE COIL WAS REPLACED WITH NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES OR DELAY. THE PATIENT¿S VESSEL WAS HEAVILY TORTUOUS AND MODERATELY CALCIFIED. A DCB2 DETACHMENT CONTROL BOX WAS ALSO USED FOR THE CASE. 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 DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363674 ↗