Thoratec recalls 2nd Gen CentriMag Primary Consoles due to risk of shutting down during power surges above 1.8kV, requiring patient switch to backup system. Affected units have specific serial numbers.
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.
Thoratec is recalling its 2nd Generation CentriMag Primary Consoles because a component change may cause the device to shut down completely during power surges above 1.8kV without warning. This could force patients to switch to a backup circulatory support system, which is critical for medical safety.
The console may shut down completely during power surges between 1.8kV and 2.0kV without any alarm. This would stop the device from pumping blood, requiring immediate manual switch to a backup system to maintain patient circulation.
Patients using the CentriMag Circulatory Support System with the recalled consoles are most at risk. The device is used for circulatory support in medical settings, so patients with specific medical conditions requiring this technology are affected.
Check for serial numbers starting with 201-90401, 201-90701, 201-90411, 201-90421, or 201-30300. The device is part of the CentriMag Circulatory Support System and has specific UDI-DI codes listed in the recall notice.
Look for the serial number on the console or in the product documentation to confirm if it's affected.
Reach out to Thoratec Switzerland GmbH for specific guidance on next steps if the console is affected.
The console may shut down completely during power surges between 1.8kV and 2.0kV without warning, which could stop blood pumping and require switching to a backup system.
Check the serial number on the console or in the product documentation. Affected units have specific serial numbers starting with 201-90401, 201-90701, 201-90411, 201-90421, or 201-30300.
No immediate stop is required, but if you have the affected serial numbers, contact Thoratec for guidance on next steps.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-2215-2024 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-2215-2024 from Thoratec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
