Recall of Cordis Angiographic Catheter for Lack of Sterilization Deemed Class I

Cordis’s recall of Infiniti angiographic catheters for lack of sterilization has been identified by the FDA as a Class I recall, the most serious type of recall as use of these devices may cause serious injuries or death.

The Infiniti angiographic catheter delivers contrast dye to blood vessels in the brain, organs, or limbs during diagnostic procedures. The catheter is put into the body through the skin and can be used in multiple places at once. 

The use of unsterilized angiographic catheters may result in serious acquired infections, sepsis, and in extreme cases, death, however, there have been no reports of death or injury associated with this issue.

Read the FDA recall notice here.

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