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.
- Affected units
- 459
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.
Part of a larger recall action
This product is one of 10 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Heartware, Inc.
See all →- HighHVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan
FDA (Devices) · 2023-12-13
- ModerateHeartWare HVAD Implant Kit Instructional Update for Fault Alarms
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Device Updated Instructions for Alarm Conditions
FDA (Devices) · 2023-12-13
- HighHVAD Ventricular Assist Pump Model 1104CA: Instructions for Fault Alarm and Lifespan
FDA (Devices) · 2023-12-13
- ModerateVentricular Assist Device Instructions Updated for Alarm and Useful Life Clarification
FDA (Devices) · 2023-12-13
Same hazard · neurological events
See all →- CriticalHeartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures
FDA (Devices) · 2021-08-18
- CriticalFDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality
FDA (Devices) · 2021-08-18
- CriticalHeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality
FDA (Devices) · 2021-08-18
- CriticalHeartWare HVAD System Recalled Due to Higher Mortality Rates
FDA (Devices) · 2021-08-18
- CriticalHeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns
FDA (Devices) · 2021-08-18