Medical Device Safety and Recalls: Stryker Sustainability Solutions Recalls Flush Angiographic Catheter Due to Tip Separation

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Stryker Sustainability Solutions Recalls Flush Angiographic Catheter Due to Tip Separation

Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions), is recalling Angiodynamics Soft Vu Omni Flush Angiographic Catheters due to reports of separation of the tip of the catheter from the main body. Tip separation leads to loss of device function, possible surgical intervention to retrieve a separated segment, or other complications such as blocking blood flow to bodily organs.

Tip separation can also lead to internal organ injury and cause stroke, kidney failure, and intestinal failure among other serious adverse health consequences, including death.

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