www.fdanews.com/articles/177651-reports-of-catheter-breakage-triggers-recall
Reports of Catheter Breakage Triggers Recall
July 22, 2016
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