# FDA recall Z-1229-2023

> **Datascope Corp.** · Class II · device recall initiated 2023-02-07.

## Product

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, and 0998-00-0800-55

## Reason for recall

There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart.  In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.

## Distribution

US Nationwide.  Global Distribution.

## Key facts

- **Recall number:** Z-1229-2023
- **Recalling firm:** Datascope Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-07
- **Report date:** 2023-03-15

- **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-1229-2023

## Citation

> AI Analytics. FDA recall Z-1229-2023. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1229-2023. Source: US FDA. Licensed CC0.

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