Terumo Electronic Patient Gas System Recalled for Control Slider Failure
Terumo is recalling 72 Electronic Patient Gas Systems used in cardio-pulmonary bypass because a fault disables control sliders, forcing use of local knobs.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a critical medical device used during surgery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 72 units of the Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender (Catalog #: 801188, UDI 00886799000588). These devices are used in cardio-pulmonary bypass procedures.
The recall is due to an intermittent failure that causes a blender initialization fault upon start-up or during an EPGS calibration attempt. This fault leads to the Central Control Monitor control sliders being disabled, meaning the gas system can only be controlled by the local control knobs.
The affected units were distributed nationwide in the United States, including California, Connecticut, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Montana, New Mexico, New York, Ohio, and Wisconsin. They were also distributed to Canada, Mexico, and South Korea. Specific lot and serial numbers are listed in the source data.
The recalled product
- Product
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 72
Distribution
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