# FDA recall Z-1276-2023

> **Datascope Corp.** · Class II · device recall initiated 2023-02-28.

## Product

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

## Reason for recall

There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.

## Distribution

Distribution list not yet provided.

## Key facts

- **Recall number:** Z-1276-2023
- **Recalling firm:** Datascope Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-28
- **Report date:** 2023-03-29

- **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-1276-2023

## Citation

> AI Analytics. FDA recall Z-1276-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1276-2023. Source: US FDA. Licensed CC0.

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