The Recall Desk

FDA (Devices) recall action 84829

Heartware, Inc. recalled 2 products on 2020-03-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-03-18
Critical
0
Units
10,978

Why these products were recalled

Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2020-03-18

    Heartware Recalls HVAD System Battery Charger AC Adapters

    Heartware, Inc. is recalling 5,489 HVAD System Battery Charger AC Adapters because users might mistakenly insert them into the HVAD Controller power port.

    Product
    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…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-03-18

    HeartWare HVAD System Battery Charger Recalled for Adapter Insertion Risk

    Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Chargers because users may mistakenly insert the AC adapter into the HVAD Controller power port.

    Product
    HeartWare HVAD System Battery Charger 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)…
    Category
    Distribution
    0 states