# FDA recall Z-1232-2023

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

## Product

Cardiosave Rescue. Model Number: 0998-00-0800-83.

## Reason for recall

Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.

## Distribution

Nationwide US distribution. Worldwide international distribution.

## Key facts

- **Recall number:** Z-1232-2023
- **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-1232-2023

## Citation

> AI Analytics. FDA recall Z-1232-2023. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1232-2023. Source: US FDA. Licensed CC0.

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