# FDA recall Z-2215-2024

> **Thoratec Switzerland GMBH** · Class II · device recall initiated 2024-05-22.

## Product

2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System

## Reason for recall

Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.

## Distribution

Worldwide - US Nationwide distribution included in the states of CA, PA, FL, IL, NY, AR, GA, WI, AZ, TN, TX, NC, MT, VA, MA, NJ, NE, WV, ME, OK, CO, OH, KC, WA, IN, CT, MI, OR, ID, MO, SC, KY, LA, NM, NV, VT, IA, MD and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BANGLADESH, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRAN, IRAQ, ISRAEL, ITALY, KENYA, KOREA, KUWAIT, LITHUANIA, MACEDONIA MALAYSIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NORWAY, OMAN, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM.

## Key facts

- **Recall number:** Z-2215-2024
- **Recalling firm:** Thoratec Switzerland GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-22
- **Report date:** 2024-07-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2215-2024

## Citation

> AI Analytics. FDA recall Z-2215-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2215-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*