SUMMIT 2570-23-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295143857), received between Jun 2, 2023 and Aug 13, 2024 — classified as 3 malfunctions.

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

• MalfunctionAug 13, 2024Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE NUMBERS AND LINES HAVE FADED ON THE INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973597 ↗
• MalfunctionJun 2, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT DIAMETER SIZE MARKING HAS WORN AND IS DIFFICULT TO READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048700 ↗
• MalfunctionJun 2, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT DIAMETER SIZE MARKING HAS WORN AND IS DIFFICULT TO READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048580 ↗