TruClear 7209807SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521749900), received between Feb 26, 2018 and May 5, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Overheating of Device; Smoking; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Smoking; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY/POLYPECTOMY PROCEDURE FOR TISSUE REMOVAL, THE HANDPIECE BECAME EXTREMELY HOT AND DISPLAYED AN E6 ERROR CODE. THE DEVICE EMITTED A BURNING SMELL AND WAS SUBSEQUENTLY REMOVED FROM THE OPERATING ROOM, CAUSING AN HOUR DELAYED TO THE PROCEDURE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. ANOTHER HANDPIECE WAS USED, AND IT WORKED FINE. THE PROCEDURE WAS COMPLETED AS IS WITH DILATION AND CURETTAGE (DC).

  Patient problems: Insufficient Information

  MAUDE report 21961078 ↗
• InjuryJul 19, 2023Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY MYOMECTOMY, THE HANDPIECE AND BLADE JUST STOPPED WORKING AND CONTROL UNIT SAID "STALLED MOTOR, TRY NEW HANDPIECE". THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. HAND TO SWITCH OUT HANDPIECES AND BLADES AND CASE WAS ABORTED AFTER TWO BLADES AND TWO HANDPIECES WERE ATTEMPTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356541 ↗
• MalfunctionMar 27, 2019Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE PORT WHERE TUBING ATTACHES HAS DETACHED.

  Patient problems: No Information

  MAUDE report 8457215 ↗
• MalfunctionMar 27, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING REPROCESSING, DEVICE HAD BROKEN CONNECTOR. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8457193 ↗
• InjuryMar 21, 2019Break; Material Deformation; Break; Material Deformation

  ACCORDING TO THE REPORTER, THERE WAS A BROKEN PIECE MISSING OFF OF UNIT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Information

  MAUDE report 8440346 ↗
• MalfunctionJan 28, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE HAND-PIECE WAS CAUSING THE BLADE TO SKIP WHEN OPERATING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8280781 ↗
• MalfunctionDec 3, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE UNIT'S COATING/INSIDE WAS CHIPPING OFF AND WAS MISSING. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8127537 ↗
• MalfunctionOct 12, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  ACCORDING TO THE REPORTER, DURING TESTING, THE METAL PIECE SNAPPED OUT ON THE SHAFT OF THE HAND PIECE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7960437 ↗
• MalfunctionFeb 28, 2018Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7304458 ↗
• MalfunctionFeb 26, 2018Break; Break

  ACCORDING TO THE REPORTER, THE UNIT ADAPTER BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7297855 ↗