House Chair Wants Answers On The FDA’s Handling Of Dangerous Device
Executive Summary
The Chairman of the US House Subcommittee on Economic and Consumer Policy is pressing the FDA on why it allowed what he says is a dangerous medical device to stay on the market for so long.
You may also be interested in...
US FDA Slaps Another Class I Recall On Medtronic
The US FDA has identified a recall of Covidien catheters due to a hub defect as class I. The agency’s most serious designation is yet another for the company, which has recently recalled several devices.
Medtronic HVAD Recall Given High-Risk Class I Designation
A welding defect may allow moisture to enter affected heart pumps, which can lead to device failure, the US FDA explained. Medtronic first announced the recall in April.
Essure-Related Complications Still A Problem, Latest FDA Data Show
Interim data from two ongoing studies show more women have had the Essure birth control device removed while many are still experiencing adverse events, such as pain and bleeding.