HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure
Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall is classified FDA Class I, the most serious regulatory category. The source text explicitly states 'mortality' associated with the device, indicating deaths have occurred. Combined with reports of neurological adverse events and critical device malfunction risks, this meets the Critical threshold.
Plain-English summary
The HeartWare HVAD Pump Implant Kit (REF 1153) is a left ventricular assist device intended to help failing hearts pump blood. Medtronic is recalling all 163 units distributed worldwide, including throughout the United States.
Medtronic initiated this recall based on observational clinical data showing that the HVAD system is associated with a higher frequency of neurological adverse events and mortality compared to other commercially available left ventricular assist devices. Additionally, the company has received complaints that the internal pump may delay or fail to restart, posing a serious risk for patients who depend on the device.
Patients with implanted HVAD systems should contact their healthcare provider immediately to discuss their individual situation and options. Healthcare providers should verify whether they have patients with implanted units and consult Medtronic for guidance on patient management.
The recalled product
- Product
- HeartWare HVAD Pump Implant Kit, REF 1153
- Manufacturer
- Heartware, Inc.
- Hazard
- neurological-adverse-events
- mortality
- pump-failure
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)
- GTIN: 00888707000147 All serial numbers
Distribution
Distributed nationwide across the United States.
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