MANSFIELD – Medical device maker Covidien PLC is facing scrutiny from the U.S. Food and Drug Administration over the way its management handled the recall of its Duet TRS surgical staples, reported MassDevice.com.
Covidien, which finalized its acquisition of Jerusalem-based Oridion on Tuesday, pulled the staples off shelves after they were linked to 13 patient injuries and three deaths.
The FDA chided Covidien for both a lack of documentation and a delayed response to reports related to the Duet device, which were noted more than two years before the recall, according to the news site.
“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 Jan. 19, 2012,” the FDA said to Covidien in a warning letter.
The medical device maker issued warnings related to its product in January, saying that they had the potential to result in “life-threatening, post-operative complications.”