Heartware HVAD ventricular assist device recalled due to mortality risk
Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.
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 combined with explicit mention of 'mortality associated with the system' in observational clinical data meets the criteria for Critical severity per the rubric. The agency is stopping all distribution due to neurological adverse events and device malfunction complaints.
Plain-English summary
Medtronic is recalling the HeartWare HVAD Outflow Graft (REF MCS1725OG) worldwide. This is a left ventricular assist device that assists a failing heart in pumping blood. A total of 459 units were distributed.
Mediatronic is halting distribution and sale based on observational clinical comparisons showing a higher frequency of neurological adverse events and mortality with this system compared to other commercially available left ventricular assist devices. Additionally, complaints indicate that the internal pump may delay or fail to restart.
The device was distributed in the United States and in multiple international locations including Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland, Turkey, United Kingdom, and others. Patients who have received an HVAD device should contact their healthcare provider immediately to discuss these findings and review treatment options appropriate to their individual circumstances.
The recalled product
- Product
- HeartWare HVAD Outflow Graft, REF MCS1725OG
- Manufacturer
- Heartware, Inc.
- Hazard
- neurological-events
- pump-failure
- 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 (2)
- GTIN: 00888707007627
- 00888707007634 All serial numbers
Distribution
Distributed nationwide across the United States.
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