TruClear 7209208Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521746664), received between Dec 15, 2017 and Nov 20, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K013870, K031787); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 J UNE 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 18175540 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A STUDY TO COMPARE HYSTEROSCOPIC MORCELLATION WITH THE TISSUE REMOVAL SYSTEM VERSES BIPOLAR RESECTOSCOPY FOR REMOVAL OF ENDOMETRIAL POLYPS; PERFORATION OCCURRED AT DILATION IN 1 PATIENT IN THE HYSTEROSCOPIC MORCELLATION GROUP; HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONALLY, 2 PATIENTS OF THE HYSTEROSCOPIC MORCELLATION GROUP WERE DIAGNOSED WITH A URINARY TRACT INFECTION POST OPERATIVELY.

  Patient problems: Urinary Tract Infection

  MAUDE report 7819612 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A STUDY TO COMPARE HYSTEROSCOPIC MORCELLATION WITH THE TISSUE REMOVAL SYSTEM VERSES BIPOLAR RESECTOSCOPY FOR REMOVAL OF ENDOMETRIAL POLYPS; PERFORATION OCCURRED AT DILATION IN 1 PATIENT IN THE HYSTEROSCOPIC MORCELLATION GROUP; HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONALLY, 2 PATIENTS OF THE HYSTEROSCOPIC MORCELLATION GROUP WERE DIAGNOSED WITH A URINARY TRACT INFECTION POST OPERATIVELY.

  Patient problems: Perforation

  MAUDE report 7818009 ↗
• MalfunctionMay 15, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING TESTING, THE UNIT WAS NOT WORKING AND ITS FIBER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7514356 ↗
• MalfunctionApr 20, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S LENS WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7448171 ↗
• MalfunctionJan 10, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE¿S GLASS LENS WAS CRACKED. THE DEVICE WAS NOT BEING USED ON A PATIENT WHEN IT WAS DISCOVERED THAT THE GLASS IN THE SCOPE WAS CRACKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180143 ↗
• MalfunctionDec 15, 2017Break; Break

  ACCORDING TO THE REPORTER, THE UNIT¿S PART THAT WAS CONNECTED TO THE IC WAS INTERNALLY DAMAGED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7123071 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013870, K031787. One submission often covers many models, so check the product and lot details in each record.

• Z-1467-2022 · Jun 7, 2022 · Open, Classified
  TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808