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Use caution Medical device recall · FDA · Published December 2, 2019

HeartMate 3 Mobile Power Unit Recall: Static Electricity Risk

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.

🇺🇸 FDA recall #Z-0746-2020Medical deviceThoratec ›
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Recalling firmThoratec Corp.6035 Stoneridge Dr · Pleasanton, CA 94588-3270
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/66413-heartmate-3-mobile-power-unit-recall-static-electricity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66413-heartmate-3-mobile-power-unit-recall-static-electricity-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0746-2020

Cite this page

“HeartMate 3 Mobile Power Unit Recall: Static Electricity Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66413-heartmate-3-mobile-power-unit-recall-static-electricity-risk. Based on FDA recall #Z-0746-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0746-2020%22&limit=1).

Thoratec Corp. recalled the HeartMate 3 Mobile Power Unit on Dec. 2, 2019, after the FDA announced excessive static electricity could cause power loss and damage to the left ventricular assist system. The recall affects units distributed nationwide.

How to tell if you have it

  • HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883
  • HeartMate 3 Mobile Power Unit, REF 107758, UDI or GTIN: 00813024010890

The hazard

The FDA said excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit. This damage could lead to no or reduced blood flow from the left ventricular assist system.

Context

GovInfoNow's records show Thoratec Corp. has had eight other recalls on record since March 1, 2019. Recent Thoratec recalls include a May 8, 2024 HeartMate Monitor recall for screen errors and a March 1, 2024 HeartMate 3 LVAS Implant Kit recall for potential leak paths. Other recent recalls of similar products include a May 13, 2026 Thoratec HeartMate 3 LVAS Kits recall for battery failures and a May 13, 2026 HeartMate 3 System Controller recall for backup battery failures.

How to tell if you have this one

Check for serial numbers 00813024010883 or 00813024010890 on the Mobile Power Unit. The device is used when patients are indoors, stationary, or sleeping.

  • Brand
    Thoratec
  • Product
    HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Look for serial numbers 00813024010883 or 00813024010890 on the Mobile Power Unit.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 40 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

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

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, 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 terminated this recall 2.8 years after the firm started it.

1. Firm started the recall: Dec 2, 201912. FDA classified it Class II: Dec 27, 201923. Published in FDA’s Enforcement Report: Jan 8, 202034. FDA terminated the recall: Sep 14, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0746-2020 (December 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0746-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA