HeartWare Ventricular Assist System (HVAD) For use as a… recallZ-1751-2015 · HeartWare Inc · initiated Apr 29, 2015
Class II Open, Classified All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from HeartWare Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
FDA root cause category: Device Design
Recall details
- Recall number
- Z-1751-2015
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 29, 2015
- Posted by the FDA
- Jun 10, 2015
- Recalling firm
- HeartWare Inc
- Quantity
- 3,747 currently in use
- Product code
- DSQ
- FDA submissions
- P100047
- Distribution
- 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, Foreign: 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, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK,
Product description
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Code information (models, lots, serial numbers)
Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101, 1102, 1104, 1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
Other devices under the same FDA submission
33 devices cleared under P100047 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HeartWare® Controller 1403USHeartware Inc. · Ventricular (Assisst) Bypass3 recalls10 deaths1,495 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assisst) Bypass1 recall1,126 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass2 recalls606 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall615 reports
- HVAD® Pump Implant Kit MCS1705PUHeartware Inc. · Ventricular (Assist) Bypass7 recalls36 deaths203 reports
- HVAD® Controller 1403USHeartware Inc. · Ventricular (Assist) Bypass548 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall487 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assist) Bypass1 recall281 reports
- HeartWare® Battery 1650DEHeartware Inc. · Ventricular (Assist) Bypass1 recall159 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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