Terumo Cardiovascular Systems Corp 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial Numbers: 1988 through 4450, 4452 through 4457, 4459 through 4485, 4487 through 4500, 4502 through 4525, 4527 through 4545 and 4551.
Products Sold
Serial Numbers: 1988 through 4450, 4452 through 4457, 4459 through 4485, 4487 through 4500, 4502 through 4525, 4527 through 4545 and 4551.
Terumo Cardiovascular Systems Corp is recalling Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion syst due to False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.
Recommended Action
Per FDA guidance
Consignees were notified of the defect/issue and what to do if it were to occur (short term work around) via an Urgent Medical Device Removal letter dated 9/14/07. As the permanent fix users were informed the sensor will be replaced when replacements become available.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026