NA 2531-04-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295129042), received between Mar 25, 2020 and Nov 13, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT TRIAL WAS BROKEN, CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544285 ↗
• MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL HEADS WERE WORN TO THE POINT THE PLASTIC WAS FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325524 ↗
• MalfunctionFeb 8, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL HEADS WERE WORN TO THE POINT THE PLASTIC WAS FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325304 ↗
• MalfunctionOct 20, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10704999 ↗
• MalfunctionOct 20, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10704992 ↗
• MalfunctionOct 20, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10704991 ↗
• MalfunctionOct 20, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE HEADS ARE IN A BAD SHAPE. PLASTIC IS CUT FROM RETRACTS AND INSTRUMENTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10704987 ↗
• MalfunctionMar 25, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE 32 + 40MM HEAD TRIALS NEED REPLACED DUE TO SCRATCHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881086 ↗
• MalfunctionMar 25, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE 32 + 40MM HEAD TRIALS NEED REPLACED DUE TO SCRATCHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881076 ↗