HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant K

FDA device recall Z-2583-2024 · posted 2024-08-13 · Open, Classified

Recall details

Recalling firm

Thoratec LLC

Reason for recall

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

Action taken

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 continuous, steady exposure to water. 4) Reinforce requirement to patient to perform the daily self-test to verify the display works appropriately as listed on Page 2-29 "Performing a System Controller Self Test". Patients should contact the hospital in the event of display issues. Firm will follow-up with a formal notification about the lifted UI membrane.

Root cause

Process design

Status

Open, Classified

Product code

DSQ

Quantity affected

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, Aus

Date initiated

2024-06-25

Date posted

2024-08-13

Location

Pleasanton, CA