Device product
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 Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No
Z-2518-2026
Product summary
- Firm
- Thoratec LLC
- Event
- Event 99023
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-2518-2026
Official wording
Reason: Due to 11 volt Backup Battery failures.
Code information: Lot Code: Model Number: 106524US UDI/GTIN 05415067039323 Serial Numbers Distributed in US: See Attachment E for serial numbers distributed.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Due to 11 volt Backup Battery failures.