Recall Z-2291-2025 ยท DSQ Ventricular (Assist) Bypass
Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 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
| Date | Aug 13, 2025 (initiated Jun 23, 2025) |
| Status | Open, Classified |
| Reason | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect. |
| Root cause | Vendor change control |
| Action | Customer advisory letters dated June 23, 2025, will be hand delivered and by email to all impacted consignees. The customer advisory letters will be posted on the Abbott Product Advisory website for further visibility. As stated in the customer letter, affected AC Power Cords from US and OUS consignees and patient units that are experiencing connection issues will be returned and replaced. Instruction to Customers: Refer to "User Action Requested" section in attached customer letter for instructions to consignees. (Attachment D1, D2, and D3) |
| Quantity | 604 |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.