Thoratec Switzerland GMBH is recalling approximately 3,425 units of the 2nd Generation CentriMag Primary Console, which is a critical part of a circulatory support system. Due to a recent component change, the console may not be able to handle certain power surges between 1.8kV and 2.0kV. If a surge occurs, the console could shut down completely without an alarm, causing the life-supporting pump to stop and requiring an immediate switch to a backup system.
If the device is subjected to a power surge while in use, the pump will stop delivering blood circulation to the patient without warning. Because the device fails to sound an alarm during this specific failure, there is a risk of serious injury or death if the patient is not immediately transitioned to a backup support system by medical staff.
System Switch to Backup
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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