The Recall Desk
HighFDA (Devices)·Z-1698-2015·Announced 2015-06-17

HeartWare Ventricular Assist System Recalled for Damaged Power Supply Pins

HeartWare Inc is recalling HVAD systems due to complaints of damaged or bent connection pins in the power supply ports of the VAD controller.

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) where a defect could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

HeartWare Inc is recalling the HeartWare Ventricular Assist System (HVAD) because the company received complaints regarding damage or bent connection pins within the power supply ports of the VAD controller. The affected devices are used as a bridge-to-cardiac transplantation for patients at risk of death from refractory end-stage left ventricular heart failure.

The recall covers all HeartWare HVAD systems currently in use, including catalog numbers 1101 and 1103 in the US and 1100, 1101, 1102, 1104, 1104JP, and 1205 outside the US. Approximately 3,747 units are currently implanted worldwide. Distribution includes the United States and numerous international locations.

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. Product Usage: 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 — 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 nationwide across the United States.

The notice also names 32 states specifically:

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