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Medical Devices / Postmarket Safety

Reports of Catheter Breakage Triggers Recall

July 25, 2016
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Stryker Sustainability Solutions announced that it was recalling 167 Soft-Vu Omni Flush Angiographic catheters following reports of the product top breaking off during usage.

The recall, which the FDA designated a Class I recall, affects products distributed in 11 states between January 2004 and December 2008.

Tip separation can lead to internal organ injury and multiple other serious adverse events. — Cynthia Jessup

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