Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 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); Models 801763.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0093 and 0104 through 0114.
Products Sold
Serial numbers 0093 and 0104 through 0114.
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 gas system may fail calibration prior to use due to incorrect gas system flowmeter software.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
Recommended Action
Per FDA guidance
U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.
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