ATTUNE 2549-00-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295476474), received between Jan 14, 2025 and Apr 23, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENTS HAD AN UNKNOWN ALLEGATION. THIS WAS FOUND WHEN INSPECTING PANS THAT WERE RETURNED FROM SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967376 ↗
• MalfunctionApr 23, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENTS HAD AN UNKNOWN ALLEGATION. THIS WAS FOUND WHEN INSPECTING PANS THAT WERE RETURNED FROM SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967369 ↗
• MalfunctionFeb 5, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated

  IT WAS REPORTED THAT THE HOSPITAL IS COMPLAINING ABOUT TRAYS DUE TO CHIPPING, PEELING, CRACKING AND OUTER RUBBER PEELING OFF. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312236 ↗
• MalfunctionJan 14, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT PANS WERE FLAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151612 ↗