The issue described in this recall notice is the same one that is described on the Medtronic HeartWare Ventricular Assist Device (HVAD) System web page.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Medtronic HVAD Batteries
- Model Numbers: 1650DE
- Devices Being Recalled: 23,372
- Dates distributed: January 1, 2009 to present
- Date Initiated by Firm: June 28, 2022
The HeartWare Ventricular Assist Device (HVAD) System is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned. The system operates using power from either AC or DC electricity or batteries.
Reason for Recall
Medtronic, Inc. is recalling HeartWare HVAD System batteries because the batteries may experience electrical faults that cause them to unexpectedly fail. When this occurs batteries with an electrical fault may be unable to power the controller, unable to accept charge from the battery charger, or appear to remain charged when in use.
If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death.
Medtronic reports 1,159 complaints, six injuries, and one death related to this issue.
Who May Be Affected
- Health care providers who manage the care of patients with an implanted Heartware HVAD System
- Patients who have the Heartware HVAD System implanted
What to Do
On June 28, 2022, Medtronic issued an Urgent Medical Device Correction letter to affected customers about this issue as well as a previous battery recall. This letter also asked customers to take the following actions to help address the battery electrical fault:
- Keep two sources of power connected to their controller and have fully charged spare batteries available at all times.
- Acknowledge and report alarms.
- Follow the Instructions for Use (IFU) for proper power source management.
- Be vigilant if the battery indicator lights do not decrease over time while the battery is in use.
- If the lights do not decrease over time while the battery is in use, this could be a sign of battery electrical fault and the battery should not be used.
- Pay attention to the battery indicator lights.
- Do not use a battery if the indicator lights do not light up.
- Check to make sure:
- Battery capacity display lights up
- Battery indicator on the controller lights up
- Battery charger status light does not flash red or yellow after connecting the battery
The Letter provided additional instructions for customers including:
- Complete a customer confirmation form and return it to firstname.lastname@example.org.
- Share the letter with all those who need to be aware within the organization and with any organization where patients have been transferred.
- Health care providers with questions about this recall should contact their local Medtronic Representative.
- Patients with questions about this recall should contact Medtronic Patient Services at 800-635-3930 (Monday - Friday, 8 a.m. to 5 p.m. Central time).
- Medical Device Recall Database Entry
- Medtronic Medical Device Correction Letter
- Medtronic Recalls Heartware HVAD System Due to Battery Failure (June 2022)
- Medtronic HeartWare Ventricular Assist Device (HVAD) System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.