Merit Maestro® 00884450358153Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450358153), received between Feb 14, 2020 and Nov 1, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 1, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE MICROCATHETER DETACHED FROM THE REST OF THE CATHETER WITHIN THE PATIENT. THE DEVICE WAS SUCCESSFULLY RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049091 ↗
• InjuryFeb 14, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL INTRAVASCULAR PROCEDURE, THE RADIOPAQUE MARKER BAND DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED ARTERIAL ACCESS, AND WHILE MANIPULATING A MICRO CATHETER THROUGH A RUC CATHETER, THE MARKER BAND DETACHED FROM THE CATHETER YET REMAINED ON THE GUIDE WIRE. THE MARKER BAND WAS SUCCESSFULLY CAPTURED AND REMOVED WITH THE ASSISTANCE OF A SMALL PERIPHERAL BALLOON. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INJURIES OR CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9712680 ↗