The COVID-19 pandemic has changed hospital processes and made people more aware of the need to thoroughly sterilize medical instruments between patients. This article discusses some of the changes that may occur due to lessons learned throughout the global health emergency.
The government alleges that the company did not disclose serious health events in certain implantable defibrillators.
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.