BMT Medizintechnik GmbH BF-40Recalls & reported problems
BMT Medizintechnik GmbH · TOWEL CLAMP FAURE, 8,5 CM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04251725204150), received between Mar 7, 2023 and Mar 7, 2023 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypoxia1
- Pneumothorax1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "FEASIBILITY AND SAFETY OF TRANSBRONCHIAL LUNG CRYOBIOPSY FOR DIAGNOSIS OF ACUTE RESPIRATORY FAILURE WITH MECHANICAL VENTILATION IN INTENSIVE CARE UNIT." BACKGROUND: ACUTE HYPOXEMIC RESPIRATORY FAILURE IS COMMON IN INTENSIVE CARE UNITS (ICUS). LUNG BIOPSIES MAY BE REQUIRED TO MAKE A DEFINITIVE DIAGNOSIS IN PATIENTS WITH UNKNOWN ETIOLOGIES. THE FEASIBILITY OF TRANSBRONCHIAL LUNG CRYOBIOPSY IS UNDETERMINED IN PATIENTS WITH RESPIRATORY FAILURE IN THE ICU. METHODS: PATIENTS WHO UNDERWENT BRONCHOSCOPY EXAMINATIONS WITH TRANSBRONCHIAL LUNG CRYOBIOPSY (TBLC) BETWEEN JULY 2018 AND DECEMBER 2019 WERE RETROSPECTIVELY ANALYZED THROUGH MEDICAL CHART REVIEW. THE PROCEDURES WERE PERFORMED BY WELL-EXPERIENCED INTERVENTIONAL PULMONOLOGISTS. RESULTS: TEN PATIENTS UNDERWENT BRONCHOSCOPY EXAMINATIONS WITH TBLC IN THE ICU AT CHANG GUNG MEMORIAL HOSPITAL DURING THE STUDY PERIOD. IN ALL PATIENTS, THE DIAGNOSIS WAS MADE VIA PATHOLOGICAL ANALYSIS. ONE PATIENT DEVELOPED PNEUMOTHORAX AND REQUIRED CHEST TUBE PLACEMENT AFTER THE PROCEDURE. NONE OF THE PATIENTS HAD BLEEDING REQUIRING BLOOD TRANSFUSION, AND NO DEATHS WERE DIRECTLY RELATED TO THE
Patient problems: Hypoxia; Pneumothorax
MAUDE report 16499832 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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