HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients

FDA device recall Z-0005-2017 · posted 2016-10-17 · Terminated

Recall details

Recalling firm

Heartware, Inc.

Reason for recall

Loose connector ports in controller body.

Action taken

HeartWare sent an Urgent Medical Device Correction letter dated June 8, 2016, to all affected customers, HeartWare advised clinicians to remind patients to follow unit instructions and water avoidance, and to regularly schedule appointments to check the integrity of the unit and to be cautious with connectors when inspecting connectors. Clinicians were also instructed to send back the enclosed "Acknowledgement Form" within 30 days and to forward the message to necessary individuals within their organization. Customers with questions were instructed to contact their local HeartWare representative. For questions regarding this recall call 305-364-1575.

Root cause

Device Design

Status

Terminated

Product code

DSQ

Quantity affected

4235 Worldwide, 7272 units in U.S.

Distribution

Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and

Date initiated

2016-06-08

Date posted

2016-10-17

Date terminated

2020-03-31

Location

Miami Lakes, FL