FDA Device recall Z-1530-2021
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber o…
- FDA Device
- Class I
- ongoing
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class I recall of ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber o… 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-1530-2021 |
| 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
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL 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 | Assurity Pacemaker Model Number/UDI (GTIN): PM1240 / 05414734507066 PM2240 / 05414734507073 PM2260 / 05414734507097 PM1…Assurity Pacemaker Model Number/UDI (GTIN): PM1240 / 05414734507066 PM2240 / 05414734507073 PM2260 / 05414734507097 PM1272 / 05414734509572 PM2272 / 05414734509589 Serial Numbers: 7628828 7629513 7629762 7630106 7630232 7630233 7630235 7630364 7630367 7630369 7630370 7630371 7630372 7630383 7630394 7630397 7630398 7630399 7630400 7630401 7630402 7630403 7630413 7630421 7630428 7630429 7630430 7630431 7630432 7630435 7630442 7630443 7630724 7630725 7630726 7630727 7630729 7630730 7630731 7630732 7630733 7630734 7630736 7630737 7630738 7630739 7630740 7630741 7630742 7630743 7630744 7630745 7630746 7630747 7630748 7630749 7630750 7630751 7630752 7630753 7630754 7630755 7630756 7630757 7630758 7630759 7630760 7630763 7630764 7630765 7630766 7630767 7630768 7630769 7630771 7630772 7630773 7630774 7630776 7630777 7630778 7630779 7630780 7630781 7630782 7630783 7630784 7630785 7630786 7630787 7630788 7630789 7630791 7630792 7630793 7630794 7630795 7630796 7630797 7630798 7630799 7630800 763 |
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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-1530-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.