Brand Name: HeartMate Product Name: HeartMate 3" System recall
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The…
Why was Brand Name: HeartMate Product Name: HeartMate 3" System recalled?
Due to 11 volt Backup Battery failures.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: Model Number:106531US UDI/GTIN: 05415067039446 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
- Product
- Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The…
- Recalling firm
- Thoratec LLC
- Quantity
- 694
- Distribution
- Worldwide - US Nationwide distribution including in the states of 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 date
- June 24, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)