TruClear 7209509Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521744103), received between Nov 20, 2023 and May 7, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO A HYSTEROSCOPY AND CURETTAGE PROCEDURE, UNIDENTIFIED FRAGMENTS WERE OBSERVED FALLING FROM THE SHAVER TIP. THEY IMMEDIATELY REPLACED THE DEVICE WITH ANOTHER BRAND-NEW SHAVER TO COMPLETE THE PROCEDURE. NOTHING FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO INVASION OF THE PATIENT AT THE TIME THE FRAGMENTS WERE OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115894 ↗
• MalfunctionFeb 3, 2026Failure to Cut; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY POLYPECTOMY THE SOFT TISSUE SHAVER WAS NOT DISSECTING PROPERLY, APPEARED SLOW, AND SEEMED BLUNT. THE DENSE TISSUE SHAVER PLUS WAS THEN USED, BUT THE SITUATION DID NOT IMPROVE. A REUSABLE HAND INSTRUMENT WAS ALSO TRIED, RESULTING IN ONLY A VERY SLIGHT IMPROVEMENT. THE POLYP BEING REMOVED WAS OVER 3 CM IN SIZE. DUE TO THE PERFORMANCE OF THE DEVICES, THE PROCEDURE HAD TO BE COMPLETED USING BIPOLAR RESECTION, WHICH WAS NOT INITIALLY AVAILABLE IN THE HOSPITAL. THIS SWITCH EXTENDED THE SURGICAL TIME BY ONE HOUR.

  Patient problems: Insufficient Information

  MAUDE report 24244684 ↗
• InjuryJul 29, 2025Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PLUS SHAVER HAD A DETECTION ISSUE AS THEY OPENED A WRONG SCOPE. THEY HAD A MINI SCOPE INSTEAD OF A PLUS SCOPE WHICH WAS NOT COMPATIBLE WITH THE PLUS SHAVER. THE PATIENT WAS ALREADY PLACED UNDER ANESTHESIA AND THE PROCEDURE WAS CANCELLED BECAUSE THERE WAS NO PLUS SCOPE AVAILABLE. THE PROCEDURE WAS RESCHEDULED ON A LATER DATE.

  Patient problems: Insufficient Information

  MAUDE report 22642522 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY COMPARED INTRAUTERINE ADHESION FORMATION IN PATIENTS WHO UNDERWENT HYSTEROSCOPIC REMOVAL OF RETAINED PRODUCTS OF CONCEPTION OR ULTRASOUND-GUIDED ELECTRIC VACUUM ASPIRATION BETWEEN APRIL 2015 UNTIL JUNE 2022. HYSTEROSCOPIC REMOVAL WAS PERFORMED WITH THE TRUCLEAR 8.0 SYSTEM OR ELITE HYSTEROSCOPE PLUS WITH A SOFT TISSUE SHAVER PLUS OR A COMPETITOR DEVICE. FLUID BALANCE WAS MONITORED USING THE HYSTEROLUX OR A COMPETITOR DEVICE. HYSTEROSCOPES WERE INSERTED UNDER DIRECT VISION AFTER DILATING THE UTERINE CERVIX WITH DILATORS. OF 178 INCLUDED WOMEN, 92 WERE TREATED WITH HYSTEROSCOPY. COMPLICATIONS IN THE HYSTEROSCOPY GROUP INCLUDED HEMORRHAGE, PERFORATION, PERSISTENT RETAINED PRODUCTS OF CONCEPTION, AND ADHESIONS. CONVERSION TO VACUUM ASPIRATION WAS REQUIRED DUE TO HEMORRHAGE (GREATER THAN 500ML) AND BAD VISIBILITY ± POOR DISTENTION/RAPID FLUID LOSS. PERFORATION OCCURRED AT THE CESAREAN SCAR WHICH HAD MINIMAL MYOMETRIUM OVERLAY, AND RESULTED IN A SMALL BLADDER PERFORATION WHICH WAS CONFIRMED WITH CYSTOSCOPY AND TREATED WITH A BLADDER CATHETER FOR 10 DAYS. REPEAT HYSTEROSCOPY WAS REQUIRED FOR PATIENTS WITH PERSISTENT RETAINED CONTENTS AND ADH

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Incomplete Induced Abortion; Internal Organ Perforation

  MAUDE report 18175452 ↗