Thoratec LLC: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as th

Hazard

Due to 11 volt Backup Battery failures.

Details from the source

Reason for recall: Due to 11 volt Backup Battery failures. 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. Quantity: 694 Lot/code info: Lot Code: Model Number:106531US UDI/GTIN: 05415067039446 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.

UPC codes

05415067039446

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.