# FDA recall Z-2736-2017

> **Maquet Datascope Corp - Cardiac Assist Division** · Class I · device recall initiated 2017-06-16.

## Product

CS 100i Intra-Aortic Balloon Pump

## Reason for recall

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

## Distribution

Worldwide Distribution - (in over 100 countries) US (Nationwide)

## Key facts

- **Recall number:** Z-2736-2017
- **Recalling firm:** Maquet Datascope Corp - Cardiac Assist Division
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-16
- **Report date:** 2017-08-02
- **Termination date:** 2019-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2736-2017

## Citation

> AI Analytics. FDA recall Z-2736-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-2736-2017. Source: US FDA. Licensed CC0.

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