Heartware HVAD Pump Implant Kit Recalled for Electrostatic Discharge Risk
HeartWare Inc is recalling HVAD Pump Implant Kits due to a potential electrostatic discharge (ESD) hazard. The recall covers 76 units in the US and 82 internationally.
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 3/5 (High).
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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
HeartWare Inc is recalling the Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) due to a potential electrostatic discharge (ESD) hazard. The recall includes 76 units distributed in the United States and 82 units distributed internationally.
The affected products include US models 1400, 1401US, 1403US, and 1404, as well as international models 1400, 1401XX, 1407XX, and 1408. The recall applies to all Heartware controller serial numbers. Distribution in the US included 28 states and the District of Columbia, while international distribution covered 28 countries.
Consumers 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 HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
- Manufacturer
- HeartWare Inc
- Hazard
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 (7)
- US product: Model 1400
- 1401US
- 1403US
- 1404 International: Model 1400
- 1401XX
- 1407XX
- 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
Distribution
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