FDA recall, , Moderate risk
HeartMate 3 Left Ventricular Assist System Kits, System Controller, and Backup Battery
Due to 11 volt Backup Battery failures.
Summary by Recall Canary from the FDA notice
What happened
Thoratec LLC of Pleasanton, California, recalled HeartMate 3 System Controller, HeartMate 3 Left Ventricular System (LVAS) Kits, and HM 11V Li-ion Backup Battery due to 11 volt Backup Battery failures. The recall began May 13, 2026, and was added to the FDA's Enforcement Report on June 18, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Match the UDI-DI and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
HeartMate 3 Left Ventricular System (LVAS) Kits
- UDI-DI
- 05415067039323
- Model/Catalog number
- 106524US
HeartMate 3" System Controller
- UDI-DI
- 05415067039446
- Model/Catalog number
- 106531US
HeartMate HM 11V Li-ion Backup Battery, ABT
- UDI-DI
- 05415067039880
- Model/Catalog number
- 106128
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.
- Company
- Thoratec LLCPleasanton, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99023
- Recall numbers
- Z-2518-2026 to Z-2520-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
