The Recall Desk
HighFDA (Devices)·Z-1751-2015·Announced 2015-06-17

HeartWare HVAD Recall Issued for Discolored and Cracked Driveline Outer Sheath

HeartWare Inc is recalling HVAD systems due to complaints of discolored and cracked driveline outer sheaths. The recall affects 3,747 units currently in use.

What this means for you

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 system) with a structural defect (cracked sheath) that 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 where injury has not yet been reported.

Plain-English summary

HeartWare Inc is recalling the HeartWare Ventricular Assist System (HVAD) because of complaints regarding the driveline outer sheath. The specific issue involves the sheath becoming discolored and cracked. The HVAD is a medical device used as a bridge-to-cardiac transplantation for patients at risk of death from refractory end-stage left ventricular heart failure.

The recall covers 3,747 units currently in use. The affected products include catalog numbers 1101 and 1103 for the US, and 1100, 1101, 1102, 1104, 1104JP, and 1205 for outside the US. All serial numbers for HeartWare HVAD systems currently in use are included in this recall.

The devices were distributed across numerous US states and foreign countries, including Argentina, Australia, Canada, Germany, Japan, and the UK. Patients and healthcare providers should contact HeartWare Inc for further instructions on how to proceed with the recall.

The recalled product

Product
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Manufacturer
HeartWare Inc
Category
Medical Device — Ventricular Assist System
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 (5)

  • Catalog #'s US: 1101 and 1103 / OUS: 1100
  • 1101
  • 1102
  • 1104
  • 1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.

Distribution

Distributed in 32 states:

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