TruClear 72204879Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521746626), received between Jan 30, 2020 and Dec 30, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 30, 2025Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion

  IT WAS REPORTED THAT PRIOR TO USE, THE END METAL OF THE SCOPE WAS OBSERVED TO BE BENT AND SHARP. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927528 ↗
• InjuryJul 29, 2025Connection Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Connection Problem; Insufficient Device Problem Information; 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 22642430 ↗
• MalfunctionApr 3, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, THE SCOPE HAD JAGGED TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767330 ↗
• MalfunctionOct 16, 2024Material Deformation; Material Protrusion/Extrusion; Material Deformation; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, THE SCOPE WAS BENT/SHARP AT DISTAL TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461596 ↗
• MalfunctionApr 11, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, DEVICE HAD BURR ON DISTAL TIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091459 ↗
• InjuryDec 29, 2023Material Opacification; Appropriate Device Problem Term/Code Not Available; Material Opacification; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY TO VISUALIZE THE UTERINE CAVITY FOR DIAGNOSTIC PROCEDURES, THE DEVICE HAD BLANK VISION. THE PROCEDURE WAS RESCHEDULED TO CONDUCT HYSTEROSCOPY AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 18420125 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLI 10, 30, 40: 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

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

  MAUDE report 18175587 ↗
• MalfunctionAug 18, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS SHARP EDGE AT THE TIP OF SCOPE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10420409 ↗
• MalfunctionJan 30, 2020Device Displays Incorrect Message; Material Protrusion/Extrusion; Device Displays Incorrect Message; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A BURR ON TIP AND THERE WAS AN ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9647610 ↗