The company pulled the heart pump from the market last year, after the FDA received word of more than 3,000 deaths linked to various problems with the device, according to published reports.
Medtronic has reported six more injuries and one additional death related to problems with the batteries powering its HeartWare Ventricular Assist Device (HVAD), the Food and Drug Administration disclosed in a Thursday notice . That follows a May recall of 429 batteries over a welding problem that resulted in two injuries and one death.
Since its introduction more than a decade ago, the Medtronic HeartWare device has been cited in more than 3,000 reports of death made to Food & Drug Administration regulators, according to a report last year by not-for-profit website ProPublica.
“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 FDA wrote of the most recent recall.
So far, the company has received 1,159 complaints related to electrical faults with the batteries, including five reports that both batteries either malfunctioned or became disconnected from the controller, it said in an email to MedTech Dive.
The external batteries provide power to a pump implanted into the chest to help provide mechanical support to a failing heart. Medtronic pulled the HVAD system from the market in 2021, but has since had multiple Class I recalls related to the device.
Medtronic began the recall of more than 23,000 batteries on June 28 after the company found electrical faults made the batteries unable to power the system’s control device or accept a charge, or made them appear to remain charged while discharging. The company cited “an interaction between the battery software configuration and the battery circuit board that can cause electrical faults within some batteries.”
Medtronic confirmed the two recent deaths in an email but did not comment on the total number of reported deaths associated with the HVAD system.
In June 2021, Medtronic took its HVAD system off the market . On Tuesday, Medtronic issued an urgent medical device correction to inform physicians that the company will begin exchanging HVAD power sources, including batteries, AC and DC adapters, and monitor data cables with newly designed components.
The company asked physicians to inspect the components during clinic visits, and replace damaged or worn AC adapters, DC adapters, batteries and alarm adapters.
The company initiated another recall for the troubled heart pump after a patient died when two batteries simultaneously stopped working, the company said, adding to a list of safety problems with the device. Read the full article ➔
The company’s HeartWare Ventricular Assist Device System received a Class I label from the FDA following two patient injuries and one death. Read the full article ➔
Medtronic said in a letter to healthcare providers that three patients had pumps exchanged due to malfunctions; two of them died following the swap outs. Read the full article ➔
Nine months after Medtronic pulled the system off the market, Rep. Raja Krishnamoorthi is asking the FDA to provide information about how the device was regulated following reports of patient injuries and deaths. Read the full article ➔
The medtech said the move was influenced by growing evidence the system had higher mortality risks than comparable devices. FDA advised providers to use Abbott's HeartMate 3 as an alternative. Read the full article ➔
The recall was first made public in the FDA's database on April 6. Medtronic provided a different accounting of total patient deaths as of January and said the company is redesigning parts. Read the full article ➔
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While the industry continues to embrace digital health and artificial intelligence, there are still questions about how the new technologies and services need to be regulated and if they are effective.
President Joe Biden's executive order calls for SBOMs, and the FDA wants to require premarket submissions to have an inventory of third-party device components. AdvaMed is concerned the data could be exploited by hackers.
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