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Home » Labeling glitch with Boston Scientific’s Promus Element Plus prompts recall in Australia

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

August 7, 2013 By Brad Perriello

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.

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.

Filed Under: Drug-Eluting Stents, News Well, Recalls Tagged With: Australia Therapeutic Goods Administration, Boston Scientific, Exports

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