Merit MAK™ 00884450012574Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450012574), received between Apr 26, 2022 and Oct 31, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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.

• InjuryOct 31, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE FOR UPPER ARM CENTRAL VENOUS ACCESS, THE TIP OF THE GUIDEWIRE DETACHED WITHIN THE VESSEL. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED OUT FROM THE PATIENT. NO OTHER PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044407 ↗
• InjuryApr 26, 2022Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING VASCULAR ACCESS FOR A ROUTINE AV FISTULOLAPLASTY PROCEDURE, THE ACCESS WIRE GOT CAUGHT ON THE ACCESS NEEDLE WHEN THE PHYSICIAN WAS ATTEMPTING TO STRAIGHTEN THE ACCESS WIRE. BOTH ACCESS NEEDLE & ACCESS WIRE WERE WITHDRAWN FROM THE PATIENT. IT WAS NOTED BY THE PHYSICIAN THAT THE ACCESS WIRE WAS ABNORMALLY ELONGATED AND UNCOILING. FURTHER INVESTIGATION BY THE PHYSICIAN FOUND THAT PART OF WIRE HAD BEEN INADVERTENTLY SHEARED OFF WITHIN THE PATIENT. A VASCULAR SNARE DEVICE AND LARGER SHEATH WERE USED TO CAPTURE AND RETRIEVE THE FOREIGN BODY FROM THE PATIENT. NO ADDITION PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215609 ↗