Terumo Cardiovascular Systems Corporation Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. 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, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
All
Terumo Cardiovascular Systems Corporation is recalling Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 008867990005 due to The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: specific lot/serial numbers.
Reason for Recall
As stated by FDA
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Recommended Action
Per FDA guidance
The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 18, 2019 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to take the following actions: 1. Review this Medical Device Recall notice. 2. Assure that all users have received notice of this issue, and prominently display this notice where all users may access it. 3. Continue use of the device in conjunction with the backup external mechanical flowmeter found in the Terumo System 1 Accessory Kit. 4. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 5. Terumo CVS will contact users to schedule the field correction activities. Note: Terumo CVS recommends that users continue using their Terumo System 1 with EGPS, with the required backup external mechanical flowmeter, while waiting for this correction. Customers with questions are directed to the following: Terumo CVS Customer Service: 1.800.521.2818 Monday - Friday 8 a.m. to 6 p.m. ET Recall Fax: 1.734.741.6149
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