Medtronic agrees to consent decree
Medtronic agreed to stop making its SynchroMed II drug-infusion pump under a consent decree that the Department of Justice filed along with a legal complaint, reported The Wall Street Journal.
A federal judge still needs to approve the decree, but the legal complaint alleges that Medtronic did not pursue good manufacturing practices when making the pump, which is used to distribute cancer and pain medications. The complaint was filed in US District Court for the District of Minnesota.
Medtronic declined to tell the Journal if it admits to the allegations and responded that the company was addressing the issues.
The Journal noted that the FDA issued a warning letter in 2012 that said Medtronic did not address device problems, such as motor corrosion and failure to distribute medication. The Journal wrote that Medtronic told doctors in 2013 that 14 deaths were associated with the pump, which had four potential defects.