Labeling glitch with Boston Scientific's Promus Element Plus prompts recall in Australia
Some lots of Boston Scientific's Promus Element Plus Monorail stents were shipped with incorrect labeling in Australia, prompting a recall Down Under.
Boston Scientific (NYSE:BSX) shipped some of its Promus Element Plus Monorail coronary stents with the wrong labels in Australia, prompting that country's Therapeutic Goods Administration to issue a recall.
The Promus stents were shipped with incorrect directions for use Down Under, according to a TGA release. The recall affects only the incorrect DFUs, not the device itself, according to the Aussie watchdog.
Natick, Mass.-based Boston Scientific contacted cardiologists in Australia and supplied new instructions, "with specific reference to the section on 'Pre- and Post-Procedure Antiplatelet Regimen,'" according to the release.