# FDA recall Z-0221-2020

> **Thoratec Switzerland GMBH** · Class I · device recall initiated 2019-08-22.

## Product

CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

## Reason for recall

Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

## Distribution

Distribution was nationwide.  There was government distribution, but no military distribution.      Foreign distribution was made to Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-0221-2020
- **Recalling firm:** Thoratec Switzerland GMBH
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-22
- **Report date:** 2019-11-06
- **Termination date:** 2024-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Zurich, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0221-2020

## Citation

> AI Analytics. FDA recall Z-0221-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0221-2020. Source: US FDA. Licensed CC0.

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