# FDA recall Z-0091-2022

> **Datascope Corp.** · Class I · device recall initiated 2021-09-21.

## Product

Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097.  Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers.  1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 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, 0998-UC-0800-55.  2. Cardiosave Rescue. Model Number: 0998-00-0800-83.

## Reason for recall

A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

## Distribution

Worldwide distribution.  US nationwide, Australia, Brazil, Bahrain, Belgium, Canada, China, Czech Republic, Egypt, France, Germany, India, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, Pakistan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, UK, United Arab Emirates, Philippines, and Russia

## Key facts

- **Recall number:** Z-0091-2022
- **Recalling firm:** Datascope Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-21
- **Report date:** 2021-10-27

- **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-0091-2022

## Citation

> AI Analytics. FDA recall Z-0091-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0091-2022. Source: US FDA. Licensed CC0.

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