Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0023 through 0026, 0034, 0041, 0051, 0060, 0063 through 0065, 0067 through 0069, 0071 through 0089, 0091 through 0139, 0141 through 0242, 0246 through 0280, 0282 through 0297, 0299 through 0323, 0325 through 0393, 0395 through 0421, 0423 through 0436, 0440 through 0469, 0471 through 0530, 0532 through 0550, 0552 through 0569, 0571 through 0578, 0582 through 0661, 0664 through 0666, 0668 through 0731, 0734 through 0794, 0796 through 0807, 0813 through 0817, 0820 through 0857 and 0859 through 0896.
Products Sold
Serial numbers 0023 through 0026, 0034, 0041, 0051, 0060, 0063 through 0065, 0067 through 0069, 0071 through 0089, 0091 through 0139, 0141 through 0242, 0246 through 0280, 0282 through 0297, 0299 through 0323, 0325 through 0393, 0395 through 0421, 0423 through 0436, 0440 through 0469, 0471 through 0530, 0532 through 0550, 0552 through 0569, 0571 through 0578, 0582 through 0661, 0664 through 0666, 0668 through 0731, 0734 through 0794, 0796 through 0807, 0813 through 0817, 0820 through 0857 and 0859 through 0896.
Terumo Cardiovascular Systems Corp is recalling Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110. due to The air bubble detection system may falsely continue to sound the air alarm after the user has disabled it.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The air bubble detection system may falsely continue to sound the air alarm after the user has disabled it.
Recommended Action
Per FDA guidance
Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.
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