Generator, Pulsatile Flow, Cardiopulmonary Bypass
FDA adverse event reports and recall history for generator, pulsatile flow, cardiopulmonary bypass (product code JOR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 428
- Deaths
- 0
- Injuries
- 0
- Malfunctions
- 428
Reports per year
Source: FDA adverse event reports by year received, 2007–2011. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2010-12-08TerminatedOther
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI. The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
The system 8000 roller pumps may fail resulting in a persistent pump stop.
- 2010-12-08TerminatedOther
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
The system 8000 roller pumps may fail resulting in a persistent pump stop.
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