Use caution Medical device recall · FDA · Published May 8, 2024

Thoratec HeartMate Monitor Recall: Screen Errors May Cause Anxiety or Pump Failure

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1921-2024Medical device Thoratec ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmThoratec Corp.6035 Stoneridge Dr · Pleasanton, CA 94588-3270

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/55157-thoratec-heartmate-monitor-recall-screen-errors-may-cause-anxiety-or.

Source Summary by GovInfoNow · govinfonow.com/recall/55157-thoratec-heartmate-monitor-recall-screen-errors-may-cause-anxiety-or · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1921-2024

Cite this page

“Thoratec HeartMate Monitor Recall: Screen Errors May Cause Anxiety or Pump Failure.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55157-thoratec-heartmate-monitor-recall-screen-errors-may-cause-anxiety-or. Based on FDA recall #Z-1921-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1921-2024%22&limit=1).

The FDA announced on May 8, 2024, that Thoratec Corp. is recalling the Thoratec HeartMate System Monitor due to screen display issues that may lead to hemodynamic compromise or extended surgical time. The agency issued recall number Z-1921-2024 for the voluntary Class I action affecting approximately 4,842 units distributed worldwide.

How to tell if you have it

Brand: Thoratec
Product: Thoratec HeartMate System Monitor
REF numbers: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT
UDI-DI numbers: 00813024010142, 00813024010852
All Serial Numbers

The hazard

According to the FDA, the system monitor screen may display atypical behavior including overlapping screens or buttons, frozen screens, distorted text, blanks, or zeroes in place of values. Users may also encounter unresponsive buttons where they are unable to initiate a command, which could lead to anxiety, inconvenience, hemodynamic compromise, extended surgical time, and selection of the Pump Stop command.

Context

GovInfoNow's records show Thoratec Corp. has issued eight other recalls since March 1, 2019. Recent similar recalls include the Thoratec HeartMate 3 LVAS Implant Kit Recall on March 1, 2024, and the Thoratec HeartMate Touch Communication System recall on January 3, 2024. Other recent recalls of similar products include the HeartMate 3 System Controller Recall (May 13, 2026) and the Boston Scientific LUX-DX II Arrythmia Detector Recall (March 30, 2026).

How to tell if you have this one

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.

Brand
Thoratec
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Monitor Serial Number
Look for the serial number on the monitor's label to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US nationwide including Puerto Rico, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, BULGARIA, SWITZERLAND, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GUADELOUPE,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

May 8, 2024Firm started the recall
Jun 7, 2024FDA classified it Class I
Jun 19, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/55157-thoratec-heartmate-monitor-recall-screen-errors-may-cause-anxiety-or">Thoratec HeartMate Monitor Recall: Screen Errors May Cause Anxiety or Pump Failure (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1921-2024 (May 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1921-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.