Detector, Bubble, Cardiopulmonary Bypass
FDA adverse event reports and recall history for detector, bubble, cardiopulmonary bypass (product code KRL), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 148
- Deaths
- 2
- Injuries
- 1
- Malfunctions
- 134
Reports per year
Source: FDA adverse event reports by year received, 2007–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2010-10-08TerminatedOther
Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI
Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were not able to reset the alarm to allow for further air bubble detection. .
- 2008-01-24TerminatedProcess control
Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
- 2008-01-24TerminatedProcess control
Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Terumo Cardiovalvular Systems, Ann Arbor, MI 48103
False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
- 2008-01-24TerminatedProcess control
Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
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