# FDA recall Z-1907-2023

> **Datascope Corp.** · Class III · device recall initiated 2023-05-04.

## Product

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

## Reason for recall

The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.

## Distribution

International distribution in the country of Germany.

## Key facts

- **Recall number:** Z-1907-2023
- **Recalling firm:** Datascope Corp.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-04
- **Report date:** 2023-06-21

- **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-1907-2023

## Citation

> AI Analytics. FDA recall Z-1907-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1907-2023. Source: US FDA. Licensed CC0.

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