An urgent device-safety notice regarding a discontinued HeartWare Ventricular Assist Device (HVAD) from Medtronic was published following a series of complaints regarding the device and subsequent scrutiny from the company.
The devicemaker discontinued new sales and implants of its HeartWare devices in June 2021, citing several years’ worth of serious recalls and other safety events. But in the months since, the complaints have continued to roll in from the approximately 4,000 patients who had already been implanted with the device before it was taken off the market.
Medtronic’s most recent safety notice for the pump came at the end of November, sparked by nearly three dozen patient complaints received between January 2017 and mid-September of this year. In a letter (PDF) sent to healthcare providers Nov. 29, the company noted that “no critical harms or deaths” have been linked to the device’s latest issue.
That notice revolves around the HVAD’s driveline cover, a small, flexible plastic tube that is threaded onto the cable that’s inserted through the skin to connect the HeartWare implant to its external controller. The cover is placed over the cable’s connection to the controller for protection.
Read the full article at Fierce Biotech.