Medtronic, Inc. is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two cell battery packs used to power the system, according to an alert on the US Food and Drug Administration (FDA) website.
“The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging,” the FDA says.
The agency has identified this as a class I recall, the most serious type because of the potential for serious injury or death.
Medtronic reports one death associated with this recall and two complaints in the affected lot.
Back in April, as reported by theheart.org | Medscape Cardiology, Medtronic alerted providers that patients implanted with the Medtronic HVAD System who develop pump thrombosis could have a welding defect in the internal pump that causes the pump to malfunction.
The batteries from the recalled lot have a model number of 1650DE, were manufactured from April 13 to 19, 2021 and distributed from April 20 to July 19, 2021. The recall affects a total of 429 devices.
On May 5, 2022, Medtronic sent an urgent medical device correction notice to customers asking them to identify and quarantine all affected batteries and notify affected patients. The notice includes a patient template to help communicate directly with patients.
It also includes a customer confirmation form to initiate an exchange. The completed form should be returned to [email protected]
Medtronic is replacing the affected batteries with new product and has implemented actions to improve control of the welding process.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it’s been fraught with problems.
Earlier this month, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by theheart.org | Medscape Cardiology.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
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