HeartWare HVAD heart pump implants recalled for neurological events and mortality
Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available 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: FDA Class I classification establishes a critical-level recall. The source documents a growing body of clinical comparisons showing higher frequency of neurological adverse events and mortality associated with the HVAD system compared to alternative devices, indicating deaths have been reported in relation to this device.
Plain-English summary
Medtronic is recalling the HeartWare HVAD Pump Implant Kit (REF 1125), a left ventricular assist device intended to support heart function in patients with advanced heart failure. The recall affects 4,078 units distributed worldwide, including throughout the United States, Europe, and the Middle East.
The recall follows a growing body of observational clinical comparisons showing that HVAD users experienced a higher frequency of neurological adverse events and mortality compared to patients using other commercially available left ventricular assist devices. Additionally, Medtronic received complaints that the internal pump may delay or fail to restart, creating additional risk.
Patients who have received a HeartWare HVAD implant should contact their healthcare provider or Medtronic immediately to discuss their individual risk and available options. Physicians and facilities that have used or implanted this device should review the recall notice and communicate with affected patients.
The recalled product
- Product
- HeartWare HVAD Pump Implant Kit, REF 1125
- Manufacturer
- Heartware, Inc.
- Hazard
- neurological-adverse-events
- mortality
- device-restart-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 (3)
- GTIN: 00888707000222
- 00888707007641
- 00888707005685 All serial numbers
Distribution
Distributed nationwide across the United States.
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