Merit Maestro® 00884450038468Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450038468), received between Jun 4, 2020 and Jun 4, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT DURING A LEFT UTERINE FIBROID EMBOLIZATION [UFE] PROCEDURE ON (B)(6) 2020, THE MICROCATHETERS RADIOPAQUE MARKER BAND DETACHED WITHIN A PATIENT. THE PHYSICIAN HAD ACQUIRED RIGHT RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION WITH A GUIDEWIRE AND A 5F GUIDE CATHETER. DURING MICROCATHETER MANIPULATIONS OVER THE WIRE WITHIN THE PATIENT'S LEFT UTERINE ARTERY THE MARKER BAND DETACHED. THE PHYSICIAN NOTED THE PATIENT'S ANATOMY WAS TORTUOUS AND VERY DIFFICULT TO NAVIGATE. THE RADIOPAQUE BAND BECAME EMBEDDED WITHIN THE PATIENT'S VASCULATURE SYSTEM THAT WAS FEEDING THE FIBROID. THE DECISION WAS MADE TO LEAVE THE FOREIGN BODY ACTING AS AN EMBOLIC WITHIN THE PATIENT. THE EMBOLIZATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THE OUTPATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO HOME WITHOUT FURTHER CONSEQUENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10119506 ↗