HeartWare HVAD System Recalled Due to Higher Mortality Rates
Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.
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 is a Class I FDA recall with explicit mention of higher mortality rates in the source text. Per the severity rubric, reported deaths anywhere in the source constitute a Critical (5) classification.
Plain-English summary
The HeartWare HVAD System, a left ventricular assist device manufactured by Heartware, Inc., is being recalled. Medtronic has stopped the distribution and sale of the device based on observational clinical comparisons.
Mediatronic reported a higher frequency of neurological adverse events and mortality associated with the HVAD System when compared to other commercially available left ventricular assist devices. Additionally, complaints have been received that the internal pump may delay or fail to restart.
The recall affects 338 units distributed worldwide, including the United States and countries across Europe, the Middle East, and Asia.
The recalled product
- Product
- HeartWare HVAD Driveline Extension Cable, REF 100
- Manufacturer
- Heartware, Inc.
- Hazard
- device-failure
- neurological-events
- mortality
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 (3)
- GTIN: 00888707009294
- 00888707000345
- 00763000187651 All serial numbers
Distribution
Distributed nationwide across the United States.
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