FDA Device recall Z-1478-2018
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1)
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Flowmeter Module (accessory to Terumo Advanced Perfusion System 1) by Terumo Cardiovascular Systems, citing 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 reloca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1478-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-19 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | IL, KY, MI |
Product
Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
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).
Identifiers
| code_info | Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Terumo Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1478-2018%22
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