FDA Device recall Z-1531-2021
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide s…
- FDA Device
- Class I
- ongoing
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class I recall of ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide s… by St Jude Medical Cardian Rhythm Management Division, citing 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 malfunctio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1531-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-03-15 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | St Jude Medical Cardian Rhythm Management Division |
| Distribution | US |
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
Identifiers
| code_info | Endurity Pacemaker Model Number/UDI (GTIN): PM1160 / 05414734507042 PM2160 / 05414734507059 PM1152 / 05414734509763 PM…Endurity Pacemaker Model Number/UDI (GTIN): PM1160 / 05414734507042 PM2160 / 05414734507059 PM1152 / 05414734509763 PM2152 / 05414734509770 PM1172 / 05414734509596 PM2172 / 05414734509602 Serial Numbers: 7649831 7650690 7650710 7650712 7650713 7650715 7650718 7650727 7650742 7650800 7650801 7650802 7650806 7650809 7650811 7650815 7650816 7650817 7650818 7650820 7650821 7650822 7650823 7650824 7650826 7650969 7650971 7650974 7650975 7650976 7650978 7650979 7650980 7650982 7650983 7650984 7650985 7650986 7650987 7650988 7650989 7650990 7650992 7650993 7650994 7650995 7650997 7650998 7651000 7651001 7651002 7651004 7651005 7651006 7651008 7651010 7651011 7651012 7651014 7651015 7651016 7651017 7651018 7651019 7651020 7651021 7651023 7651024 7651027 7651028 7651169 7651171 7651172 7651173 7651174 7651175 7651176 7651177 7651179 7651180 7651181 7651182 7651183 7651185 7651186 7651187 7651188 7651189 7651190 7651191 7651192 7651193 7651194 7651196 7651197 7651198 7651199 7651200 7651201 76 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1531-2021%22
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