Use caution Medical device recall · FDA · Published June 25, 2024

Thoratec HeartMate 3 System Controllers: Fluid Exposure May Cause False Alarms

Thoratec recalls HeartMate 3 System Controllers with specific model numbers and serials due to risk of fluid exposure causing false alarms and system failure. Affected units include certain HeartMate 3 LVAS Implant Kits and controllers.

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

🇺🇸 FDA recall #Z-2583-2024Medical device Thoratec ›

Use caution until it’s fixed

Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

Take action

Contact the company

Recalling firmThoratec LLC6035 Stoneridge Dr · Pleasanton, CA 94588-3270

✎ GovInfoNow plain-language explainer

Thoratec is recalling specific HeartMate 3 System Controllers and LVAS Implant Kits that may lift along the edge of the controller housing. If exposed to fluid, this could damage internal components and cause false alarms, loss of power, or pump stoppage. This is a serious issue for patients using these life-support devices. Read more at govinfonow.com/recall/54759-thoratec-heartmate-3-system-controllers-fluid-exposure-may-cause-false.

Source Summary by GovInfoNow · govinfonow.com/recall/54759-thoratec-heartmate-3-system-controllers-fluid-exposure-may-cause-false · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2583-2024

Cite this page

“Thoratec HeartMate 3 System Controllers: Fluid Exposure May Cause False Alarms.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54759-thoratec-heartmate-3-system-controllers-fluid-exposure-may-cause-false. Based on FDA recall #Z-2583-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2583-2024%22&limit=1).

Thoratec LLC is voluntarily recalling the HeartMate 3 System Controllers provided within certain HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits, according to an FDA announcement on June 25, 2024. The agency issued recall number Z-2583-2024 for the device class II recall.

How to tell if you have it

HeartMate 3 LVAS Implant Kit, US, Model: 106524US
HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT
HeartMate 3 System Controller, US, Model: 106531US
HeartMate 3 System Controller, OUS, Model: 106531INT
HeartMate 3 System Controller Low Flow 2.0, Global, Model: 106531LF2

The hazard

The left ventricular assist system controller UI membrane or screen may lift along the edge of the controller housing. If the controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies and result in unexpected alarms, loss of visual alarms, loss of user interface functions, loss of power, and pump stop.

Context

GovInfoNow's records show Thoratec LLC has five other recalls on record since March 13, 2025. Other recent recalls include the HeartMate 11V Backup Battery Recall (May 13, 2026), the Thoratec CentriMag Blood Pump Recall (Oct. 10, 2025), and the HeartMate 3 Controller Recall (Oct. 9, 2025). Other recent recalls of similar products include the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), the Medline Open Heart Kits Recall (Nov. 26, 2025), and the Medline Heart Cath Pack-LF Kits Recall (March 24, 2026).

How to tell if you have this one

Check for the following model numbers: 106524US, 106524INT, 106531US, 106531INT, 106531LF2. Also look for the specific serial numbers listed in the recall notice, which include HSC-134168 and other HSC codes.

Brand
Thoratec
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Controller Model
Identify your HeartMate 3 System Controller model number (e.g., 106531US) and serial number (e.g., HSC-134168) to determine if it's affected.
Contact Thoratec
Reach out to Thoratec directly for assistance with the recall process and to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed in 41 states and D.C., and outside the U.S.

FDA distribution: “US: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA, NE, CA, OK, CO, DC, IN, MI, CT, UT, IA, MD, OR, NM, ME, SC, KY, LA, WA, NV, HI, AL, MS, KS, WV. OUS: Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 57 days after the firm started it.

Jun 25, 2024Firm started the recall
Aug 13, 2024FDA classified it Class II
Aug 21, 2024Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if my controller is affected?

Contact Thoratec directly to confirm if your device is affected and follow their instructions for the next steps.

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Link to this recall

<a href="https://govinfonow.com/recall/54759-thoratec-heartmate-3-system-controllers-fluid-exposure-may-cause-false">Thoratec HeartMate 3 System Controllers: Fluid Exposure May Cause False Alarms (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-2583-2024 (June 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2583-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.