Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
FDA adverse event reports and recall history for extracorporeal system for long-term respiratory / cardiopulmonary failure (product code QJZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 497
- Deaths
- 27
- Injuries
- 41
- Malfunctions
- 429
Reports per year
Source: FDA adverse event reports by year received, 2020–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-05-15Open, ClassifiedDevice Design
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
- Open, ClassifiedUnder Investigation by firm
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.
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