Recall Z-0506-2026 ยท DSQ Ventricular (Assist) Bypass
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Powe
| Date | Nov 14, 2025 (initiated Oct 9, 2025) |
| Status | Open, Classified |
| Reason | Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. |
| Root cause | Device Design |
| Action | On 10/09/2025, the firm sent via email an "URGENT MEDICAL DEVICE RECALL (CORRECTION)" Letter to customers informing them that Abbott has observed an increase in customer complaints about the controller Backup Battery Fault Alarm. The issue is potentially due to excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller which results in corrosion of the ribbon cable connectors. What Customers should know: When the Backup Battery Fault Alarm is active, this Advisory alarm will appear as a flashing yellow wrench on the user interface and Call Hosp |
| Quantity | 35376 |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Algeria, Australia, Austria, Azerbaijan, Bahra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.