FDA also supports the removal of the HeartWare HVAD System from the market.
Nearly 32,000 stent systems have been recalled in the United States.
A product issue could cause keys to become unresponsive or stuck, leading to infusion delays.
Reported issues related to the device include two injuries and one death.
The medical device reports describe both patient infections and other possible contamination issues.
The company was accused of hiding serious health risks related to implantation of its transvaginal surgical mesh products.
There have been 29 complaints, including 19 serious injuries and two deaths, related to the device issue.
All commercial, clinical, R&D and manufacturing activities surrounding the product will end.
Physicians need technology that helps them track disease progression and response to therapy.
The non-profit organization states that 60–70% of KN95 masks tested do not filter 95% of aerosol particulates.