US Food & Drug Administration Recalls Johnson & Johnson Heart Valve

By Joe Messa

Jan 03

On Tuesday, January 2, 2018, The United States Food & Drug Administration (FDA) issued a Class I recall of Johnson & Johnson Agilis Steerable Introducer Sheath valve devices. The recall includes about 110 heart devices distributed between January 1 and May 5.

A Class I recall is the strictest recall classification issued by health regulators, reserved for situations where the use of defective devices can cause catastrophic injury or death.

The recalled valve is a component of device a that is used to insert and position cardiovascular catheters into the heart. The valve’s main purpose is to prevent blood from flowing backwards through it.

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About the Author

Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More