Defective devices Archives

Reuters (6/27, Kuber) reports the US Food and Drug Administration has criticized Covidien Plc for not responding promptly to three deaths and 13 serious injuries related to its thoracic surgery devices. The FDA said that despite receiving several complaints about the devices since May 2009, Covidien did not recall the devices until regulators initiated an investigation into the complaints on January 19 of this year. "Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice," the FDA said in its letter to Covidien, dated June 14.