The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1607-2014·Announced 2014-05-21

HeartWare HVAD Pump Implant Kit Battery Recall for Support Issues

HeartWare Inc is recalling HVAD Pump Implant Kit batteries that may not provide two hours of support or behave unusually.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (ventricular assist device) where a functional defect (battery failure) poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

HeartWare Inc is recalling HeartWare HVAD Pump Implant Kit batteries. The recall involves 32,349 units distributed worldwide, including the United States and numerous international locations.

The recall is issued because some batteries may not provide two hours of support or may behave unusually. The HeartWare Ventricular Assist Device is designed for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.

Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.

The recalled product

Product
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and…
Manufacturer
HeartWare Inc
Category
Medical Device — Ventricular Assist Device
Hazard
Affected units
32,349

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 (2)

  • Catalog# USA:1650 // OUS: 1650
  • 1650-DE All HeartWare Battery Serial Numbers

Distribution

Distributed in 37 states:

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