Thoratec recalls HeartMate System Monitors with specific serial numbers due to screen errors that could cause anxiety, pump issues, or extended surgery time. Affected units may display overlapping buttons, frozen screens, or distorted text.
System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected
Thoratec is recalling HeartMate System Monitors with certain serial numbers because their screens may show errors like frozen displays or distorted text. These issues could cause anxiety, lead to pump problems, or extend surgery time if not fixed.
The monitor screen may display overlapping buttons, frozen screens, distorted text, or blank values. This can cause users to feel anxious, lead to pump complications, or require longer surgery times if they mistakenly select the Pump Stop command.
Patients using the HeartMate system monitor for left ventricular assist devices are most at risk. The recall affects all units with specific serial numbers listed in the notice.
Check the serial number on the monitor's label. Affected units include those with serial numbers starting with 00813024010142 or 00813024010852, as listed in the recall notice.
Look for the serial number on the monitor's label to confirm if it is affected.
The monitor screen may display errors like overlapping buttons, frozen screens, or distorted text, which could cause anxiety, pump issues, or extended surgery time.
Check the serial number on the monitor's label. If it matches the affected numbers listed, contact Thoratec for further instructions.
The recall states potential issues like anxiety and pump complications, but does not mention a risk of serious injury in normal use.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-1921-2024 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-1921-2024 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.
