MICRUSFRAME MFR140711Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704079347), received between Jan 12, 2022 and Aug 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, AFTER THE INTRODUCTION OF THE COIL, A 7MM X 11CM MICRUSFRAME 14 (MFR140711 / 31136249), IT COULD NOT BE RELEASED. IT WAS REPORTED THAT THE PHYSICIAN WANTED TO PULL THE COIL OUT OF THE ANEURYSM, BUT IT BECAME PREMATURELY DETACHED. THE PROCEDURE WAS DELAYED BY 20 MINUTES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053413 ↗
• MalfunctionJan 12, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL COIL EMBOLIZATION, A CERENOVUS COIL WAS PLACED WITHOUT TROUBLE AND THEN A MICRUSFRAME14 7MMX11CM COIL (MFR140711, LOT UNKNOWN) WAS BEING USED AS THE SECOND COIL. HOWEVER, THE COIL COULD NOT BE ADVANCED WITHIN PRESHAPED PROWLER14 MICROCATHETER (606151FX, LOT UNKNOWN). THUS, THE COIL AND THE MC HAD TO BE WITHDRAWN. A NEW CERENOVUS COIL WAS USED WITH A NEW MC AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL DID NOT APPEAR DAMAGED, IT COULD SIMPLY NOT BE PUSHED ANY FURTHER WITHIN THE MICROCATHETER. AFTER ADVANCEMENT WAS NOT POSSIBLE, WITHDRAWAL WAS TRIED BUT ALSO IMPOSSIBLE, THE COIL GOT STUCK. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235372 ↗