# FDA recall Z-1950-2020

> **Cardiac Assist, Inc** · Class II · device recall initiated 2020-03-06.

## Product

TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product:  5710-6217 - Product Usage:  provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

## Reason for recall

Failure to prime due to an assembly error

## Distribution

US Nationwide distributions.

## Key facts

- **Recall number:** Z-1950-2020
- **Recalling firm:** Cardiac Assist, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-06
- **Report date:** 2020-05-20
- **Termination date:** 2020-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pittsburgh, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2020

## Citation

> AI Analytics. FDA recall Z-1950-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1950-2020. Source: US FDA. Licensed CC0.

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