Thoratec recalls HeartMate 3 Mobile Power Unit models with specific serial numbers due to static electricity causing power loss that may reduce blood flow from the assist system.
Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
Thoratec is recalling HeartMate 3 Mobile Power Units with certain serial numbers because static electricity can cause power loss, potentially leading to reduced blood flow from the left ventricular assist system. This is a serious risk for patients using the device at home or in clinical settings.
Static electricity can cause the Mobile Power Unit to lose power, which may damage the left ventricular assist system. This could lead to reduced blood flow, potentially causing health complications for patients relying on the device.
Patients using the HeartMate 3 Left Ventricular Assist System with the recalled Mobile Power Units are most at risk. The device is used when patients are indoors, stationary, or sleeping.
Check for serial numbers 00813024010883 or 00813024010890 on the Mobile Power Unit. The device is used when patients are indoors, stationary, or sleeping.
Look for serial numbers 00813024010883 or 00813024010890 on the Mobile Power Unit.
Static electricity can cause power loss in the Mobile Power Unit, potentially damaging the left ventricular assist system and reducing blood flow.
Check the serial numbers on the Mobile Power Unit. If it matches the recalled numbers, contact Thoratec for guidance.
The device is safe to use if it does not have the recalled serial numbers. Otherwise, it may cause power loss and reduced blood flow.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-0746-2020 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-0746-2020 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.
