Monarch™ Platform MON000005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B634MON0000050), received between Oct 17, 2019 and Aug 25, 2022 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF LUPUS AND A RECENT BRONCHOSCOPY FOR A BIOPSY OF THE LEFT LUNG NODULE RETURNED TO THE HOSPITAL THE FOLLOWING MORNING FOR PAIN IN THE LEFT CHEST AND REQUESTED A CHEST X-RAY FOR FURTHER EVALUATION. THE PATIENT DENIES SHORTNESS OF BREATH BUT REPORTS INCREASED PAIN WITH DEEP BREATHING. THE PATIENT DID HAVE A POST PROCEDURE X-RAY DONE FOLLOWING THE PROCEDURE WHICH SHOWED NO PNEUMOTHORAX. THE PATIENTS PAIN STARTED ON THE WAY HOME FROM THE PROCEDURE THE PREVIOUS DAY. A THORA VENT WAS PLACED INTO THE LEFT CHEST. SUCTIONING WAS USED FOR ABOUT AN HOUR. A REPEAT X-RAY AT THAT TIME SHOWED NEAR COMPLETE RESOLUTION OF THE PNEUMOTHORAX ON THE LEFT. THE PATIENT CONTINUED TO FEEL WELL AND WAS NOT HOSPITALIZED. THE PATIENT RETURNED THE FOLLOWING DAY TO HAVE THE THORA VENT REMOVED AND REPORTED TOLERATED THE DEVICE WELL, NO SHORTNESS OF BREATH AS WELL AS NO SIGNIFICANT LEFT CHEST PAIN.

  Patient problems: Chest Pain; Pneumothorax

  MAUDE report 15298112 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 9/23/2019, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS NOTED TO BE IN THE SAME AREA AS THE TARGET LESION. THE CUSTOMER CONFIRMED THAT THE CUSTOMER RECEIVED A CHEST TUBE AND SHORTLY RECOVERED AND WAS RELEASED. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, THERE WAS NO DEVICE FAILURE. IT WAS THE CUSTOMER'S BELIEF THAT THE PNEUMOTHORAX COULD BE ATTRIBUTED TO THE BIOPSY THAT WAS PERFORMED WITH NON-AURIS INSTRUMENTS.

  Patient problems: Pneumothorax

  MAUDE report 9203529 ↗

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