Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. 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; Model 801763.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0011 through 0363 may be affected. Serial numbers 0011, 0014, 0023, 0038, 0043, 0047, 0119, 0145, 0245, 0253, 0254, 0256, 0260, 0265, 0278, 0280, 0284, 0295, 0305, 0310, 0317, 0333, 0341, 0343, 0351, 0356 and 0360 have been corrected and the other serial numbers listed will be corrected.
Products Sold
Serial numbers 0011 through 0363 may be affected. Serial numbers 0011, 0014, 0023, 0038, 0043, 0047, 0119, 0145, 0245, 0253, 0254, 0256, 0260, 0265, 0278, 0280, 0284, 0295, 0305, 0310, 0317, 0333, 0341, 0343, 0351, 0356 and 0360 have been corrected and the other serial numbers listed will be corrected.
Terumo Cardiovascular Systems Corp 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 subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operatio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.
Recommended Action
Per FDA guidance
Firm repaired the affected units beginning in November 2005, upon receipt of complaints of failure. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components 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