Terumo Advanced Perfusion System 1 Electronic Patient Gas System — Class II medical device recall Z-1769-2019
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2019-06-19, distributed nationwide. An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibratio
| Recall number | Z-1769-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2018-10-17 |
| Classified | 2019-06-11 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2020-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, KR, MX |
| Quantity | 72 |
| UPC / GTIN / UDI-DI | 00886799000588 |
| Serial numbers | 01380, 01381, 01382, 01383, 01384, 01385, 01386, 01387, 01388, 01389, 01394, 01395, 01396, 01397, 01398, 01405, 01406, 01407, 01408, 01410, 01411, 01413, 01414, 01415, 01416 and 20 more |
| Model numbers | 801188 |
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Reason for recall
An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1769-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.