St. Jude Medical, Cardian Rhythm Management Division FDA Recalls

2 recalls on file across devices, 2 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ENDURITY Pulse Generator REF PM** SN ******* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers Class IMar 15, 2021Due to a manufacturing issue associated with the mixing proc	Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacema	Class IDevices	Mar 15, 2021
ASSURITY Pulse Generator REF PM** SN ******* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended toClass IMar 15, 2021Due to a manufacturing issue associated with the mixing proc	Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacema	Class IDevices	Mar 15, 2021