Recall Z-2583-2024 · DSQ Ventricular (Assist) Bypass

Thoratec LLC

HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System Controller, US, Model: 106531US; HeartMate 3 System Controller, OUS, Model: 106531INT; HeartMate 3 System Controller Low Flo

Date	Aug 13, 2024 (initiated Jun 25, 2024)
Status	Open, Classified
Reason	Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop
Root cause	Process design
Action	On 6/25/24, verbal and email communications were initiated informing customers of the following: 1) Carefully inspect the controller at the edge near the display button to confirm the UI membrane is not lifted (refer to provided visual examples). 2) Report Controllers with lifted UI membrane by contacting Firm's Technical Support at 1-800-456-1477. 3) Reinforce requirement as listed on Page 2-11 "System Controller Warnings and Cautions" in the IFU to patients to protect controller from water. Advise them to follow instructions to avoid direct exposure to water; and communicate risk of continu
Quantity	694
Distribution	US: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA, NE, CA, OK, CO, DC, IN, MI, CT, UT, IA, MD, OR, NM, ME, SC, KY, LA, WA, NV, HI, AL, MS, KS, WV. OUS: Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands,
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.