The U.S. FDA posted notice of a class I recall for two hemodialysis catheters made by Covidien Inc., the Palindrome and Mahurkar catheters, due to a catheter hub defect that could lead to mixing of venous and arterial blood. No deaths and only one injury have been reported in connection with the defect, but the recall affects more than 1 million devices that went into distribution starting in June 2017, one of the numerically larger recalls in recent years.
When it put down a casual $43 billion to merge with Covidien in 2015, Medtronic inherited its Irish partner’s Dublin headquarters and wide range of medical devices—and, consequently, any and all of their accompanying safety issues.
Medtronic, which inherited the Pipeline Flex embolization device in its nearly $43 billion acquisition of Covidien in early 2015, initiated the recall in July. This week, the FDA categorized it as Class I, the agency’s most severe, linking the device in question to an increased risk of serious injury or death.
Covidien Asks 1st Circ. To Hand It Ex-Worker's Device Patents
Epizyme, in the midst of a partial clinical hold on a test for its experimental med tazemetostat, has hired a new chief medical officer.
Johnson & Johnson’s expanding cash hoard is fueling speculation of a major acquisition, but Chief Executive Officer Alex Gorsky isn’t talking like someone with a big deal in the offing.
As questions mount about the viability of Valeant Pharmaceuticals International Inc.’s business model, concerns are spreading to other drug makers seen as following a similar playbook.
Pharma Company Xcelience Expands, Adds 100 Jobs
Mallinckrodt Buys Ikaria for $2.3 Billion for Neonatal Care