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 0039, 0041 through 0308, 0310 through 0313, 0315, 0316
Products Sold
Serial numbers 0011 through 0039, 0041 through 0308, 0310 through 0313, 0315, 0316, 0319 through 0321 and 0324 may be affected by this issue. Serial numbers 0238 and 0282 have been corrected to date.
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 System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the central control monitor.
Recommended Action
Per FDA guidance
The firm corrected the complaint units at the time of the complaints in 2005. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their system will be corrected when 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