# FDA recall Z-2616-2021

> **Datascope Corp.** · Class II · device recall initiated 2021-09-08.

## Product

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

## Reason for recall

The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is  installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during  a very specific set of conditions.

## Distribution

Nationwide domestic distribution. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-2616-2021
- **Recalling firm:** Datascope Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-08
- **Report date:** 2021-10-06

- **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-2616-2021

## Citation

> AI Analytics. FDA recall Z-2616-2021. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-2616-2021. Source: US FDA. Licensed CC0.

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