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Patient Information Regarding the HVAD™ System

Medtronic has stopped the distribution and sale of the HVAD™ System as of June 3, 2021, and has notified physicians to cease new implants of the Medtronic HVAD™ System and transition to an alternative commercial LVAD for all future implants. Prophylactic explant of the HVAD™ System is not recommended at this time.

Medtronic initiated this action in light of a growing body of observational clinical comparisons demonstrating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD™ System as compared to other commercially available left ventricular assist devices (LVAD).

In addition, Medtronic previously made an Urgent Medical Device Communication informing physicians that the HVAD™ pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death.

Considering these findings and the availability of alternative devices, Medtronic made the decision to stop the distribution and sale of the HVAD™ System, consistent with its commitment to prioritize patient safety.

Patient safety is our foremost priority. We recognize this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them, in coordination with their physicians.

We know the greatest commitment Medtronic makes to patients and their healthcare providers is to consistently make safe and effective devices that alleviate pain, restore health, and extend life. As Medtronic delivers new innovative medical technology for the future, we will continue to embrace our responsibility as a leader in the development and manufacture of safe and effective lifesaving medical technologies.

An Open Letter to Medtronic Patients

Dear Patient:

As you may be aware from a letter from your physician’s office, Medtronic has decided to stop the distribution and sale of the HVAD™ System, the pump that you have implanted to treat your heart condition.

The decision was made because a growing body of clinical data shows that patients who have the HVAD system are more likely to experience neurological events, such as strokes, and death compared to other commercially available left ventricular assist devices. In addition, Medtronic determined that the HVAD™ pump may experience a delay to restart or a failure to restart after it is stopped (for example during controller exchange).  Pump restart failure can potentially result in death, worsen your heart condition, lead to a heart attack, and require hospitalization. 

At Medtronic, patient safety is our first priority, and we are doing everything possible to minimize any risks to your health.  With that in mind, below we have included a summary of important information and recommendations regarding your HVAD™ System. 

  • Medtronic recommends that you continue to follow-up regularly with your surgeon, physician, or VAD Coordinator and follow your healthcare providers’ advice and directions.  In consultation with an independent panel of clinician advisors, Medtronic does not recommend that you have your HVAD™ device removed or replaced. 
  • Medtronic will provide ongoing product support for the HVAD™ System and will ensure continued availability of peripherals, including the Pioneer controller.
  • Medtronic reminds you to never disconnect your HVAD™ pump from two power sources at the same time and to always have a back-up controller and fully charged spare batteries available. 

We are committed to serving the needs of patients currently implanted with the HVAD device and will continue to support you and all current HVAD™ implant patients for the years ahead.  We are moving as quickly as possible to create an ongoing support program for all patients, caregivers, and health care professionals who participate in their care, including financial assistance for eligible patients. This includes the ongoing availability of product support, including the Pioneer controller and peripherals. With recommendations from an independent panel of clinician advisory and other experts, we will work to swiftly and effectively address the needs and concerns of patients while staying fully committed to working with physicians to minimize potential risks associated with the HVAD™ System. 

We recognize this information may be concerning for you and your caregivers. If you have questions, please contact your physician to speak about your Medtronic device and what it may mean to you and the treatment of your condition.

It is important that you and your doctor review your personal situation together. In consultation with an independent panel of clinician advisors, Medtronic does not recommend that patients have their HVAD™ device removed or replaced, as risks associated with explanation may outweigh the potential benefits.  The decision whether to explant and exchange the HVAD™ device should be made by physicians on a case-by-case basis, considering the patient’s clinical condition and surgical risks. If a physician determines that pump exchange is appropriate, we recommend exchanging to an alternative commercial LVAD.

As always, you or your physician should notify Medtronic of any adverse events or performance issues associated with use of the HVAD™ System. Adverse events or issues related to the performance of the HVAD System may also be reported to the FDA's MedWatch Adverse Event Reporting program. 

 

Expand All

Why is Medtronic stopping the distribution and sale of the HVAD™ System?

Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD™ System as compared to other circulatory support devices available to patients.

In addition, Medtronic previously made an Urgent Medical Device Communication informing physicians that the HVAD™ pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death.

I was implanted with the HVAD™ System – am I in danger?

Since the HVAD™ System will no longer be sold/distributed, will Medtronic stop helping me maintain my device?

When will Medtronic provide more information to patients about ongoing support?

Should I have my device replaced with another company’s device?

Is there someone at Medtronic I can contact about this?