The Recall Desk
SevereFDA (Devices)·Z-1731-2015·Announced 2015-06-24

HeartWare HVAD Recall Issued for Internal Controller Alarm Battery Failures

HeartWare Inc. is recalling HVAD systems due to internal controller alarm battery failures. The recall affects 3,747 currently implanted devices worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as Class I recalls involve a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

HeartWare Inc. is recalling the HeartWare Ventricular Assist System (HVAD) due to complaints regarding internal controller alarm battery failures. The affected devices are used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

The recall covers all HeartWare HVAD systems currently in use, with 3,747 units currently implanted. The devices were distributed worldwide, including in the United States and numerous international countries. Specific catalog numbers affected include US: 1101 and 1103, and OUS: 1100, 1101, 1102, 1104, 1104JP, and 1205.

Patients and healthcare providers should contact HeartWare Inc. for further instructions regarding the recall and potential replacement or repair of the affected devices.

The recalled product

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.
Manufacturer
HeartWare Inc
Category
Medical Device — Cardiovascular
Hazard
Affected units
3,747

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial #: ALL HeartWare HVAD systems currently in use.

Distribution

Distributed in 32 states:

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