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Faulty Valve Leads FDA to Issue a Recall of Heart Device Made by Johnson & Johnson

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.

JnJ heart valve recall pic

Visit the FDA websites linked below for more information about the recall of these devices

Sterilmed Reprocessed Agilis Steerable Introducer Sheath recalled due to improper seal of the sheath hub – https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm590903.htm

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

 

Additional Sources
FDA issues recall on Johnson & Johnson heart device

https://www.cnbc.com/2018/01/02/fda-issues-recall-on-johnson-johnson-heart-device.html

FDA issues recall on J&J heart device

https://www.reuters.com/article/us-johnson-johnson-fda/fda-issues-recall-on-jj-heart-device-idUSKBN1ER1L6