S-ROM 2576-18-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295146643), received between Mar 29, 2019 and Mar 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Illegible Information

  IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665138 ↗
• MalfunctionFeb 25, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE S-ROM SLEEVE TRIALS ARE EITHER DIFFICULT TO IMPOSSIBLE TO READ THE SIZE. THIS IS A SAFETY CONCERN FOR THE SURGEON WHO CAN'T EASILY DETERMINE THE SIZE OF THE TRIAL SLEEVE BEING INSERTED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752908 ↗
• MalfunctionMar 29, 2019Display Difficult to Read; Naturally Worn; Display Difficult to Read; Naturally Worn

  IT WAS REPORTED THAT THE OFFICE SETS WERE WORN AND NOT ABLE TO READ. DID NOT EFFECT A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466276 ↗