HeartWare Inc: HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

Recall number

Z-1731-2015

Recalling firm

HeartWare Inc

Product

HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

Status

Open, Classified

Initiated

2015-04-29

Posted

2015-06-13

Terminated

not on file

Reason

Complaints with the HVAD Internal Controller Alarm Battery failures.

Root cause

Device Design

Action

Urgent Medical Device Correction letters were sent to customers. The letter identified the affected product, as well as the reason for the recall and risks involved. HeartWare requests that customers review and familiarize themselves with the letter and "Patient Communication," and ensure that all necessary individuals are aware. Patients currently being supported by the device should be identified and given the "Patient Communication." A HeartWare representative can provide assistance with that process if needed. The "Acknowledgement and Completion Form" should be completed, signed, and returned within 30 days of the receipt of the letter. Customers can contact their local HeartWare representative with questions or concerns. Clinical Support personnel are also available at 1-888-494-6365.

Quantity

3,747 curently implanted

Distribution

Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.

Lot, serial or model codes

Serial #: ALL HeartWare HVAD systems currently in use.

510(k) numbers

not on file

PMA numbers

["P100047"]

Product code

DSQ

Firm FEI

3007042319

Firm city

Miami Lakes

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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