Thoratec LLC: Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventri

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: 4 Lot/code info: Lot Code: Model Number: 106524US UDI/GTIN 05415067039323 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.

UPC codes

05415067039323

Source

Official record: FDA (Device enforcement) ↗

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