ev3 Rounds Up Recalled Catheters

Company launches redesign of product.

By: Editor

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ev3 Inc. has voluntarily recalled its TrailBlazer Support Catheters after receiving a request from the U.S. Food and Drug Administration (FDA) to do so, according to the Plymouth, Minn., firm.

The FDA sent a letter, dated Nov. 6, 2009, to the firm seeking a recall of the product, after the company received reports of cracking on the device from physicians during the initial limited market release of the device in the United States, according to the company.

In December, ev3 launched a redesigned TrailBlazer Support Catheter that is currently available globally, the company said.

For more information, visit www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=86793.

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