Hemolung® CR4 Controller 21000Recalls & reported problems
Alung Technologies, Inc. · Hemolung® CR4 Controller · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850046004056), received between Feb 24, 2023 and Feb 24, 2023 — classified as 2 injuries.
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
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Anemia1
- Arrhythmia1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT OF A PATIENT WHO EXPERIENCED A CARDIAC ARRHYTHMIA DURING SUPPORT WITH A HEMOLUNG RAS CONTROLLER. THE CARDIAC ARRHYTHMIA REQUIRED ONE OR MORE MEDICAL INTERVENTIONS IN ORDER TO PREVENT PERMANENT INJURY.
Patient problems: Arrhythmia
MAUDE report 16440352 ↗InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ALUNG TECHNOLOGIES, INC. RECEIVED A REPORT THAT A PATIENT EXPERIENCED SEVERE AND ACUTE ANEMIA DURING SUPPORT UTILIZING A HEMOLUNG RAS CONTROLLER. THE ANEMIA WAS MANAGED THROUGH ADMINISTERING FOUR UNITS OF PRBCS DURING A 24-HOUR PERIOD.
Patient problems: Anemia
MAUDE report 16435622 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.