The Recall Desk
SevereFDA (Devices)·Z-1323-2013·Announced 2013-05-22

Heartware Recalls HVAD Pump Implant Kits Due to Driveline Connector Loosening

Heartware Inc. is recalling 3,544 HVAD Pump Implant Kits worldwide because the driveline connector may loosen.

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 Class II, and the product is a critical medical device (Ventricular Assist Device) where a structural defect (loosening connector) poses a significant risk of harm.

Plain-English summary

Heartware Inc. of Miami Lakes, FL is recalling 3,544 units of the Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device). The recall is due to the potential loosening of the HVAD Pump driveline connector.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The specific serial numbers involved are HW001-HW3827 for both US and international markets, and HW1000-HW10675 for international markets.

Consumers and healthcare providers should contact Heartware Inc. for further instructions regarding the recall and potential replacement or repair of the devices.

The recalled product

Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Manufacturer
Heartware Inc
Category
Medical Device — Ventricular Assist Device
Hazard
Affected units
3,544

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

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