HeartMate HM 11V Li-ion Backup Battery Recall
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 is recalling 12 units of the HeartMate 11V Li-ion Backup Battery due to battery failures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 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, medical-devices.
What Happened Thoratec LLC initiated a voluntary recall due to 11 volt Backup Battery failures.
Which Products Are Affected Brand Name: HeartMate. Product Name: HM 11V Li-ion Backup Battery, ABT. Model/Catalog Number: 106128. Quantity: 12 units. The product is a component of the HeartMate 3 System Controller. Distribution: US Nationwide including 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, Spain. Recall Number: Z-2520-2026. Recall Initiation Date: 20260513. Classification: Class II.
What You Should Do Refer to the FDA recall notice for further guidance on affected units.
Why This Matters The backup battery provides emergency power to the HeartMate 3 Left Ventricular Assist System Controller.
Source FDA recall Z-2520-2026, Thoratec LLC, Pleasanton, CA.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (950 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.