Terumo Cardiovascular Systems Corporation Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.
Products Sold
catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.
Terumo Cardiovascular Systems Corporation is recalling Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated due to Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav
Recommended Action
Per FDA guidance
TERUMO Cardiovascular Systems communicated with their affiliate, Terumo Dubai, in 2009 at the time the complaints were reported. No further communication was warranted. For questions regarding this recall call 734-741-6173.
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