St. Jude Medical, Cardian Rhythm Management Division

2 recalls •

• Categories: Implants & Prosthetics

ENDURITY Pulse Generator REF PM SN ***** St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

Class I - Dangerous

Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough

Mar 15, 2021 Implants & Prosthetics Nationwide View Details →

ASSURITY Pulse Generator REF PM SN ***** ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

Class I - Dangerous

Mar 15, 2021 Implants & Prosthetics Nationwide View Details →

ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

ENDURITY Pulse Generator REF PM SN ***** St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

ASSURITY Pulse Generator REF PM SN ***** ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.