Issues with the implantable heart pump’s controller date back to at least April 2010, when HeartWare said a July 2009 redesign aimed at waterproofing the controllers inadvertently made them airtight and created problems with the controller’s speaker. In February 2015 the company recalled controllers made before the FDA’s 2012 approval of the HVAD pump; further field warnings following in April 2015 and April 2016 detailing a trio of potential issues.
In a Jan. 3 letter to physicians that was posted by German regulators last week, Medtronic said the new HVAD controller is designed to address those issues, which include the potential for worn alignment guides, internal “double disconnect (no power) alarm” battery failure and loose power and data connectors.
Medtronic said it also upgraded the internal circuitry for the new device, which is dubbed “controller 2.0,” and is recalling older controllers and their DC adapters.
“The removal of these HVAD controllers and DC adapters will occur concurrently with the introduction of the new HVAD controller,” the company wrote.
“While HeartWare recommends that all patient HVAD controllers be exchanged, clinicians should weigh the benefits of the updated HVAD controller against the risks of a controller exchange procedure. Based on data reported to HeartWare, 0.2% of patients who underwent a controller exchange experienced a serious adverse event that required additional intervention. Serious adverse events reported were inclusive of neurological event, events requiring resuscitative efforts, and death due to pump failing to re-start after the controller exchange,” Medtronic wrote.
Medtronic closed the $1.1 billion HeartWare deal last August.
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