FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Stryker’s Catheter Breakage Prompts Recall

Aug. 2, 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. — Tamra Sami

View today's stories