Reported Jun 17, 2015 · Ongoing
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205.…
HeartWare Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HeartWare Inc · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- HeartWare Ventricular Assist System (HVAD). Catalog #'s
- US1101
- and 1103 / OUS
11001101110211041104JP and 1205
- Product UsageFor use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure
- Lot codes and dates
- Serial #: ALL HeartWare HVAD systems currently in use.
- Amount recalled
- 3,747 currently implanted worldwide
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Stop using this product now
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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