TruClear 72204753Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556583685), received between Oct 27, 2017 and Dec 6, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionDec 6, 2017Break; Break

  ACCORDING TO THE REPORTER, ON THE CENTRAL STERILE DURING REPROCESSING, THE DEVICE SCOPE WON'T GO DOWN THE SHEATH AND THE OTHER ONE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7089508 ↗
• MalfunctionOct 27, 2017Bent; Break; Bent; Break

  ACCORDING TO THE REPORTER, DURING THE CLEANING PROCESS, TWO SAME DEVICES WERE DAMAGED. THE SHEATHS WERE BOTH BENT AND ONE WAS BROKEN IN HALF WHEN SOMEONE TRIED TO STRAIGHTEN IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6984565 ↗