Terminated

HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

FDA Recall Z-0005-2017 · Posted 2016-10-17

Recalling FirmHeartware, Inc.

Recall StatusTerminated

Product CodeDSQ

Date Initiated2016-06-08

Date Terminated2020-03-31

Product Quantity4235 Worldwide, 7272 units in U.S.

Reason for Recall

Loose connector ports in controller body.

Firm Action

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

Distribution Pattern

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 WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.