The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller."

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…
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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