Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
Serial Numbers: 0011 through 0610, 1001 through 1034, 1037 through 1049, 1100 and 1103 through 1174.
Products Sold
Serial Numbers: 0011 through 0610, 1001 through 1034, 1037 through 1049, 1100 and 1103 through 1174.
Terumo Cardiovascular Systems Corporation is recalling Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source r due to The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.
Recommended Action
Per FDA guidance
An "Urgent Medical Device Correction" letter was sent to consignees on November 7, 2008. The letter described the reason for correction and provided instructions to customers. Terumo Cardiovascular Systems Corporation will replace the power manager boards on the affected devices. Customers were instructed to complete and fax the Customer Response Form to CVS Customer Service at 1-800-292-6551 (US only) or respond by telephone at 1-800-521-2818. Please direct questions to CVS Customers Service at 1-800-521-2818.
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