Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
S/N: 01751 UDI: 00886799000588
Products Sold
S/N: 01751 UDI: 00886799000588
Terumo Cardiovascular Systems Corporation is recalling Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 due to intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs
Recommended Action
Per FDA guidance
Terumo notified the regional affiliate to address the single EPGS device in Panama via email on 6/8/21. Letter states reason for recall, health risk and action to take: Terumo CVS will execute a field correction to replace the one (1) affected EPGS device. A Terumo Representative will contact you to schedule the field correction activities. 1. Review this Medical Device Correction and assure the user has received notice of this issue. 2. A Terumo representative will contact the user to schedule the field correction activity. Note: Terumo CVS recommends that users continue using the affected Terumo System 1 while waiting for this correction. We encourage you to contact your local Terumo representative with any questions or concerns.
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 noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026