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Labeling glitch with Boston Scientific's Promus Element Plus prompts recall in Australia

Wed, 08/07/2013 - 12:01pm
Mass Device

Some lots of Boston Scientific's Promus Element Plus Monorail stents were shipped with incorrect labeling in Australia, prompting a recall Down Under.

Labeling glitch prompts Promus Element Plus recall in Australia

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.

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