Medtronic Recalls Additional Faulty HeartWare HVAD Batteries

Medtronic is recalling 23,372 HeartWare HVAD System batteries due to the risk that they could unexpectedly fail, the US Food and Drug Administration (FDA) says in an alert posted on its website.  

Electrical faults in the batteries could make them unable to power the system’s controller, accept charge from the battery charger, or appear to remain charged when in use, the FDA says.

“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,” the agency says.

The FDA has identified this as a class I recall, the most serious type.

Medtronic reports 1159 complaints, six injuries, and one death related to this issue.

Medtronic sent an urgent letter to affected customers detailing this issue, as well as a previous battery recall for the HeartWare HVAD System involving a welding defect.

The letter advises that patients keep two sources of power connected to their controller, have fully charged spare batteries handy, acknowledge and report alarms, and follow instructions for power source management.

They should also “be vigilant” if the battery indicator lights do not decrease over time while the battery is in use, as this could be a sign of an electrical fault in the battery.

Healthcare providers with questions about this recall should contact their local Medtronic representative.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012.

Since then, it’s been fraught with problems, leading the company to stop selling the device in June 2021 for safety concerns, as reported by | Medscape Cardiology.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.

Source: Read Full Article