The Recall Desk
SevereFDA (Devices)·Z-2096-2016·Announced 2016-07-27

Stryker Recalls Angiographic Catheters Due to Tip Breakage

Stryker is recalling 167 AngioDynamics Soft Vu Omni Flush Angiographic Catheters because the tips broke off before use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Stryker Sustainability Solutions is recalling 167 units of the AngioDynamics Soft Vu Omni Flush Angiographic Catheter, Model Number 10732203. The recall was initiated because the tips of two catheters broke off prior to being used on patients.

The affected products were distributed worldwide, including in the United States and Canada. In the US, the products were distributed to the states of Texas, Utah, Pennsylvania, California, Vermont, Massachusetts, Washington, Virginia, New York, Maryland, and Connecticut.

Healthcare facilities should stop using the affected catheters and contact Stryker Sustainability Solutions for instructions on how to return the products.

The recalled product

Product
AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
Affected units
167

Distribution

Distributed in 11 states: