ATTUNE 2545-01-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295423607), received between Feb 10, 2020 and Mar 17, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT RECENTLY THE OPERATING ROOM STAFF HAS BEEN FINDING BLACK SPECS IN THE SETS. THEY ARE VERY SMALL BLACK SPECS. THEY ASKED THE OPERATING ROOM TO SEND ME SAMPLES OF THESE BLACK SPECS. THEY WERE MOSTLY FOUND ON THE BOTTOM OF THE TRAYS INSIDE THE WRAPPERS. A FEW TIMES THEY FOUND SPECS INSIDE THE CORNER PROTECTORS THAT THEY USED. THE INSIDE WRAP WAS WHITE SO THEY ARE EASY TO IDENTIFY. WHAT THEY FOUND WAS THAT THE BLACK BUMPERS ON THE TRAYS WHICH PROVIDES PROTECTION WAS PEELING OFF. PERHAPS DURING THE TRANSPORTATION AND STACKING OF TRAYS THE BUMPER MATERIAL BREAKS DOWN. NOT SURE IF YOU HAVE RECEIVED ANY OTHER CONCERNS ABOUT THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842799 ↗
• MalfunctionFeb 10, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS FOUND THAT PAN IS PEELING AND FLECKS ARE COMING OFF POTENTIALLY CONTAMINATING INSTRUMENT SET. NOTHING BROKEN, NOTHING FELL INTO PATIENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9688812 ↗