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St. Jude Medical, Cardian Rhythm Management Division Recalls
2 recalls on record · May 19, 2021 to May 19, 2021 · Medical Devices
May 19, 2021Medical DevicesFDA
St. Jude Medical, Cardian Rhythm Management Division recalls ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers
Hazard: 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
May 19, 2021Medical DevicesFDA
St. Jude Medical, Cardian Rhythm Management Division recalls ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to
Hazard: 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