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.
Boston Scientific won a nod for the Promus Element Plus from Health Canada in April of last year, adding CE Mark approval in the European Union for the device in October 2012.