The FDA warns Covidien on missing documentation and delayed management of its recall of the Duet TRS surgical staples that were implicated in 13 patient injuries and 3 deaths.
The FDA wants Covidien (NYSE:COV) to defend its management of the recall of its Duet TRS surgical staples, which were pulled off the shelves after they were implicated in 13 patients injuries and 3 deaths.
The FDA chided the device maker for its lack of sufficient documentation and delayed response to adverse event reports associated with the Duet device, which were first noted more than 2 year prior to the recall.
"Despite receiving numerous complaint, adverse event, and serious adverse event information since May of 2009 regarding use of the Duet TRS, a [corrective and preventative action] investigation was not initiated until January 19, 2012," according to the FDA warning letter.
"Covidien is working to address the FDA's concerns related to our North Haven, Connecticut facility and the Duet TRS product manufactured there," a company spokesperson told MassDevice.com today. "We will respond to the FDA within the specified timeframe and address these issues in a timely manner."
Covidien issued warnings in January 2012 contraindicating its Duet TRS single-use heads for use in thoracic surgery after determining that "Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications."
The company noted at the time that it was working with the FDA and other worldwide regulatory bodies to modify the product's instructions and warn against using Duet TRS in thoracic procedures. The Mansfield, Mass.-based device maker also placed a hold on its global Duet TRS inventory to conduct relabeling.