Reported Mar 18, 2020 · Ongoing
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in…
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 HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
- Lot codes and dates
- Model Number1640, all Serial Numbers. Known Model
- Numbers (Serial Numbers) GTIN Numbers
336 of 336 codes
1640CA (BAC004576) 008887070012981640GB (BAC004765) 008887070013281640GB (BAC004768) 008887070013281640AR (BAC004772) 008887070012741640IN (BAC004829) 008887070005431640DE (BAC005530) 008887070013041640CA (BAC005842) 008887070012981640CA (BAC005854) 008887070012981640BR (BAC005875) 008887070012811640BR (BAC005876) 008887070012811640GB (BAC005920) 008887070013281640AU (BAC005966) 008887070012671640AU (BAC005980) 008887070012671640IN (BAC005997) 008887070005431640AU (BAC006001) 008887070012671640IL (BAC006027) 008887070013351640IT (BAC006032) 008887070013421640IN (BAC006033) 008887070005431640IN (BAC006034) 008887070005431640IN (BAC006035) 008887070005431640IN (BAC006036) 008887070005431640IL (BAC006037) 008887070013351640IL (BAC006038) 008887070013351640GB (BAC006039) 008887070013281640DE (BAC006040) 008887070013041640DE (BAC006041) 008887070013041640DE (BAC006056) 008887070013041640CA (BAC006087) 008887070012981640IN (BAC006102) 008887070005431640IN (BAC006104) 008887070005431640DE (BAC090005) 008887070023251640CH (BAC090006) 008887070023181640CH (BAC090012) 008887070023181640GB (BAC090079) 008887070023321640IT (BAC090082) 008887070023631640IT (BAC090083) 008887070023631640GB (BAC090084) 008887070023321640CH (BAC090165) 008887070023181640CH (BAC090166) 008887070023181640DE (BAC090167) 008887070023251640DE (BAC090168) 008887070023251640DE (BAC090170) 008887070023251640GB (BAC090171) 008887070023321640GB (BAC090172) 008887070023321640IT (BAC090173) 008887070023631640IT (BAC090174) 008887070023631640DE (BAC090175) 008887070023251640IN (BAC090237) 008887070023561640IN (BAC090238) 008887070023561640DE (BAC090414) 008887070023251640DE (BAC090415) 008887070023251640DE (BAC090416) 008887070023251640DE (BAC090417) 008887070023251640DE (BAC090447) 008887070023251640DE (BAC090448) 008887070023251640IT (BAC090611) 008887070023631640AU (BAC090659) 008887070022881640AU (BAC090660) 008887070022881640CA (bac090661) 008887070023011640CA (BAC090662) 00888707002301
- Amount recalled
- 5,489 devices total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
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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