Recall Z-1531-2021— St. Jude Medical, Cardian Rhythm Management Division
Class I · Ongoing
Class I FDA medical device recall by St. Jude Medical, Cardian Rhythm Management Division, initiated 2021-03-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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.
- Recalling firm
- St. Jude Medical, Cardian Rhythm Management Division
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-03-15
- Firm location
- Sylmar, CA, United States
Product description
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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.