Recall Z-2518-2026 ยท DSQ Ventricular (Assist) Bypass
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 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 ass
| Date | Jun 18, 2026 (initiated May 13, 2026) |
| Status | Open, Classified |
| Reason | Due to 11 volt Backup Battery failures. |
| Root cause | Under Investigation by firm |
| Action | On 05/13/2026, the firm sent email an "URGENT MEDICAL DEVICE RECALL" Letter informing customers that As of April 27, 2026, Abbott received twenty-four (24) complaints where an advisory warning, Replace Backup Battery, was triggered once certain 11V Backup Batteries were connected to the System Controller. This warning is displayed as a yellow banner on the HeartMate Touch Monitor and System Monitor. This advisory alert is only visible when using HeartMate Touch or the System Monitor in the clinic, it is not visible to the patient. Customers are instructed to: 1. Read this notification thoro |
| Quantity | 4 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.