# FDA recall Z-0099-2019

> **Maquet Datascope Corp - Cardiac Assist Division** · Class I · device recall initiated 2018-09-20.

## Product

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

## Reason for recall

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

## Distribution

US Nationwide; Internationally to 77 countries

## Key facts

- **Recall number:** Z-0099-2019
- **Recalling firm:** Maquet Datascope Corp - Cardiac Assist Division
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-09-20
- **Report date:** 2018-11-07

- **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-0099-2019

## Citation

> AI Analytics. FDA recall Z-0099-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0099-2019. Source: US FDA. Licensed CC0.

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