Monarch™ Platform (Refurbished) MON000005RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B634MON000005R0), received between May 24, 2021 and May 24, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K173760); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET AND PNEUMOTHORAX LOCATION WERE IN THE RIGHT MIDDLE LOBE (RML). A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS DISCHARGED TWO DAYS AFTER BEING HOSPITALIZED.

  Patient problems: Pneumothorax

  MAUDE report 11873893 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173760. One submission often covers many models, so check the product and lot details in each record.

• Z-0025-2020 · Apr 19, 2019 · Terminated
  Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120