Class II — Terumo Cardiovascular Systems Corporation
| Recalling firm | Terumo Cardiovascular Systems Corp. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation). |
| Product | Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system. |
| Quantity | 7 |
| Distribution | Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore. |
| Initiated | 2018-01-19 |
| Classified | 2018-04-20 |
| Terminated | 2018-07-18 |
| Recall number | Z-1478-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Terumo Cardiovascular Systems Corporation (Z-1478-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79624/
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