Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Descrip

FDA device recall Z-2291-2025 · posted 2025-08-13 · Open, Classified

Recall details

Recalling firm

Thoratec LLC

Reason for recall

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.

Action taken

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)

Root cause

Vendor change control

Status

Open, Classified

Product code

DSQ

Quantity affected

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

Date initiated

2025-06-23

Date posted

2025-08-13

Location

Pleasanton, CA