# FDA recall Z-1478-2018

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2018-01-19.

## Product

Flowmeter Module (accessory to Terumo Advanced  Perfusion System 1).    Provides the interface between the flow sensor and the system.

## Reason for recall

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).

## Distribution

Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.

## Key facts

- **Recall number:** Z-1478-2018
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-19
- **Report date:** 2018-05-02
- **Termination date:** 2018-07-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1478-2018

## Citation

> AI Analytics. FDA recall Z-1478-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1478-2018. Source: US FDA. Licensed CC0.

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