Covidien (NYSE:COV) said today that an FDA clearance means it can get its Pipeline brain embolism device back on the U.S. market immediately, nearly 5 months after a voluntary recall of the Pipeline coil and the Alligator retrieval device.
Covidien recalled some of the Pipeline and Alligator devices in April, after internal testing revealed a potentially lethal problem with the guidewires used to deliver them. No patient incidents were reported in relation to the problem with a plastic coating used in both devices.
Covidien initiated the recall April 1 after discovering that the coating, made of polytetrafluoroethylene, could delaminate and detach. Today Covidien said it spent the intervening months working with its suppliers on a fix to the coating process. FDA approval of the manufacturing change for the Pipeline device means Covidien can put it back on the market immediately, "dependent upon manufacturing builds," a spokeswoman told MassDevice.com today via email.
A separate submission covering the same change to the Alligator manufacturing process is pending at the watchdog agency, Covidien said.
Covidien acquired the Pipeline device when it bought eV3 in the summer of 2010 for $2.6 billion in cash. Pipeline won FDA approval in March 2011.