Merit MAK™ 00884450022030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450022030), received between May 30, 2023 and Aug 22, 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT POST-PROCEDURE AN X-RAY AND CT SCAN HAD IDENTIFIED A PORTION OF THE ACCESS WIRE THAT HAD DETACHED WITHIN THE PATIENT'S CAROTID ARTERY DURING THE PROCEDURE. THE CLINICAL STAFF WAS NOT AWARE OF THIS EVENT DURING THE ACTUAL MEDICAL PROCEDURE, SO THE FOREIGN BODY WAS NOT EXTERNALIZED FROM THE PATIENT. THE PATIENT WAS EDUCATED ABOUT THIS EVENT POST PROCEDURE AND WAS ADMITTED TO THE HOSPITAL FOR CONTINUOUS MONITORING.

  Patient problems: Foreign Body In Patient

  MAUDE report 17599188 ↗
• InjuryMay 30, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT THE TIP BROKE OFF APPROXIMATELY 1-2MM AND WENT IN TO THE PATIENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027405 ↗