SILVER SPRING, MD — Stryker Solutions is recalling its Angiodynamics Soft-Vu Omni Flush angiographic catheters because of receiving reports of separation of the tip of the catheter from the catheter body[1]. Tip separation leads to loss of device function.
Surgical interventions may be required to retrieve a separated segment. Complications such as blocked blood flow to bodily organs can occur and cause stroke, kidney failure, intestinal failure, and possibly death.
The manufacturing dates for the recalled devices run from November 7, 2003 to October 18, 2008. Distribution dates run from January 5, 2004 to December 3, 2008, according to the US Food and Drug Administration (FDA) recall notice, which contains affected lot numbers.
Stryker has asked all customers to stop using the devices and dealers to check all inventories and ship affected products to Stryker.
Healthcare professionals and patients can report adverse events or side effects to the FDA using MedWatch.
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Cite this: Stryker Recalls Angiodynamics Angiographic Catheters - Medscape - Jul 22, 2016.
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