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.
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 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 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
- Affected units
- 3,544
Distribution
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Similar recalls
- CriticalHeartware HVAD Pump Implant Kit Recalled for Driveline Connector Separation
FDA (Devices) · 2014-04-30
- SevereHeartWare HVAD Pump Driveline Splice Kit Recalled for Failure Risk
FDA (Devices) · 2015-05-20
- HighHeartware HVAD Pump Implant Kit Recalled for Electrostatic Discharge Risk
FDA (Devices) · 2013-08-07
- SevereHeartware Recalls HVAD Pump Implant Kits Due to Graft Tears and Screw Breakage
FDA (Devices) · 2020-06-03
- SevereHeartWare HVAD Pump Recalled for Foreign Material in Driveline Connector
FDA (Devices) · 2016-10-19
- CriticalHeartWare Ventricular Assist System Recalled for Driveline Connector Pin Retraction
FDA (Devices) · 2015-06-17