HeartMate 3 LVAS Kits Recall Issued by Thoratec
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Thoratec LLC has initiated a Class II recall of four HeartMate 3 Left Ventricular System (LVAS) Kits due to 11 volt Backup Battery failures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened Thoratec LLC is recalling HeartMate 3 Left Ventricular System (LVAS) Kits because of 11 volt Backup Battery failures.
Which Products Are Affected The recall involves the HeartMate 3 Left Ventricular System (LVAS) Kits, Model/Catalog Number 106524US. Four units are affected. Distribution includes US nationwide (AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI) and the countries of Canada, Germany, Japan, Netherlands, Poland, and Spain. Lot Code details and serial numbers are listed under UDI/GTIN 05415067039323. Recall number Z-2518-2026.
What You Should Do The recalling firm initiated the action via letter. Affected users should refer to the provided serial number attachment for specific units distributed in the US.
Why This Matters The recall affects a small number of devices used for advanced heart failure patients worldwide.
Source FDA recall Z-2518-2026, event ID 99023. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
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Similar body length
Nearest notices by article body length (1,038 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.