The U.S. Food and Drug Administration has issued a Class I Recall involving Medtronic’s HeartWare HVAD System batteries. The recall states that the Medtronic HeartWare HVAD System batteries may have electrical faults leading to battery failure. Class I Recalls are the most severe type of recall, and using the recalled products can lead to severe injuries or death. The affected Medtronic HVAD Batteries have a model number of 1650DE. This recall affects more than 23,000 Medtronic HVAD batteries distributed from January 1, 2009, until the present.
Medtronic’s HeartWare Ventricular Assist Device (HVAD) System helps the heart pump blood throughout the body. The HVAD system bridges cardiac transplants in patients who are at risk of dying from end-stage left ventricular heart failure, as destination therapy (DT) in patients for whom heart transplants are not planned, and for heart tissue recuperation. The HVAD System uses power from either batteries or AC or DC electricity.
According to Medtronic, Inc., their HeartWare HVAD System battery recall was initiated after reports of the batteries experiencing electrical faults leading to unexpected failures. When the batteries sustain an electrical fault, they may be incapable of powering the controller, unable to charge, or incorrectly appear charged when in use. Should these batteries fail and the patient is unable to replace the battery or connect to AC or DC power, the HVAD pump will stop operating, leading to severe injury or death.
Medtronic has reported that more than 1,150 complaints have been received concerning the issue. Medtronic has received six reports of injuries and one fatality related to this issue.
Who Can Be Affected By The Recalled HVAD Batteries?
- Healthcare professionals who care for patients implanted with the Heartware HVAD System
- Patients who are implanted with Heartware HVAD Systems.
Medtronic published an Urgent Medical Device Correction letter on June 28, 2022, concerning the issue and a previous battery recall. This Urgent Medical Device Correction letter also urges customers to take the following actions:
- Have two power sources connected to their controller and keep extra fully charged batteries ready at all times.
- Report all alarms.
- Follow all “Instructions for Use” regarding power source management.
- Be watchful if the battery indicator lights do not decrease over time as the batteries are in use.
- Should the battery lights not decrease while the battery is being used, this might be a sign of a battery electrical fault. That battery should not be used.
- Watch the battery indicator lights.
- Never use batteries if the indicator lights do not light up.
- Check to ensure:
- The battery capacity display light is working.
- The battery indicator light on the controller works.
- The battery charger status light is not flash yellow or red after connecting the battery.
Healthcare professionals with questions about the battery recall should contact their Medtronic representatives. Patients should contact Medtronic Patient Services. Healthcare professionals and patients should report any adverse reactions or quality issues concerning these devices to MedWatch by FAX, online form, or regular mail.
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