# FDA recall Z-3243-2018

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2018-08-28.

## Product

Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures.    Catalog Number 801764

## Reason for recall

Screws on a Terumo¿ Advanced Perfusion  System 1 Power Manager Board (the base unit circuit board) were not torqued to specification.  It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and  may loosen over time, resulting in the potential for an electrical short in the system

## Distribution

Nationwide  Foreign:   Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam

## Key facts

- **Recall number:** Z-3243-2018
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-28
- **Report date:** 2018-10-03
- **Termination date:** 2020-04-23

- **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-3243-2018

## Citation

> AI Analytics. FDA recall Z-3243-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3243-2018. Source: US FDA. Licensed CC0.

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