On January 2, 2018, the U.S. Food and Drug Administration (FDA) issued a Class I recall impacting 112 units of Agilis Steerable Introducer Sheath devices manufactured and sold by Johnson & Johnson between January 1st and May 5th, 2017.
The Class I recall of the heart device is the strictest type of recall issued by the agency, and is only issued when the use of a medical device may cause serious injury or death.
Visit the FDA websites linked below for more information about the recall of these devices
Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall – Improper Seal of Sheath Hub – https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm590951.htm
FDA issues recall on Johnson & Johnson heart device
FDA issues recall on J&J heart device