TruClear 7209808SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521749917), received between Jan 10, 2018 and Sep 5, 2024 — classified as 3 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 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.

• MalfunctionSep 5, 2024Intermittent Energy Output; Intermittent Energy Output

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE UNIT ITSELF SHORTED OUT AND DOES NOT WORK. THE HANDPIECES WOULD NOT WORK WHEN PLUGGED INTO THIS UNIT. THERE WAS ANOTHER CONTROL UNIT AT THE FACILITY AND THAT UNIT WORKED AND WERE ABLE TO RULE OUT A HANDPIECE OR FOOT PEDAL ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147402 ↗
• MalfunctionMay 2, 2018Break; Mechanics Altered; Break; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING TESTING, THE DEVICE WOULD NOT WORK AND HAND PIECE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7479941 ↗
• MalfunctionJan 10, 2018Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE PART OF THE UNIT THAT CONNECTS THE HAND PIECE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7180171 ↗