GLOBAL CAP 2230-81-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295105107), received between Dec 10, 2018 and Oct 14, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TWO INSTRUMENTS ARE WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631504 ↗
• MalfunctionOct 14, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TWO INSTRUMENTS ARE WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631503 ↗
• MalfunctionOct 3, 2019Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE SHAPERS WERE BROKEN DUE TO USAGE. THEY WERE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151576 ↗
• MalfunctionOct 3, 2019Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE SHAPERS WERE BROKEN DUE TO USAGE. THEY WERE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151573 ↗
• MalfunctionDec 10, 2018Break; Break

  HANDLE BROKE OFF.

  Patient problems: Not Applicable

  MAUDE report 8147381 ↗