In June 2021, Medtronic stopped selling and distributing its HeartWare Ventricular Assist Device (HVAD) System after it racked up numerous Class I recalls and reports of patient injuries and deaths.
One year later, the heart pump is still being recalled due to devices harming patients.
In April, Medtronic began a recall due to a weld defect that could cause the pumps to rotate incorrectly. The issue was tied to two patient injuries and one death. In May, the company recalled HVAD batteries after identifying another weld defect that caused batteries to stop providing power or fail to hold a charge; the issue was also associated with one patient death.
The Food and Drug Administration published notices on both Class I recalls this June.
The newest recalls add to a list of product safety problems with Medtronic. CEO Geoff Martha addressed the issue in January at J.P. Morgan’s annual healthcare conference, calling product recalls his top priority.
Currently, there are about 3,500 patients with the HVAD System implanted, according to Medtronic. The company has maintained in emailed statements from this month that “explant of HVAD devices is not recommended, as risks associated with explantation may outweigh the potential benefits.”
Below is a collection of MedTech Dive's coverage of the HVAD saga.
