ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
Check against the official notice below — it lists the full affected range.
St. Jude Medical is recalling approximately 242,945 Assurity and Endurity pacemakers manufactured between 2015 and 2018 due to a manufacturing defect in the epoxy mixing process. The affected pacemakers may malfunction because moisture can enter the device through the header and feedthrough. The models involved include PM1240, PM2240, PM2260, PM1272, and PM2272, and the devices were distributed worldwide, including throughout all U.S. states and numerous countries.
Patients with recalled pacemakers can identify whether their device is affected by checking their serial number against the extensive list of affected units provided in the recall. The recall notice does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: Worldwide distribution: U.S (nationwide) to states including.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.( countries): [806 Amendment - after March 2021 - updated 3/20/2023] Algeria, Angola, Argentina, Aruba, Australia, Aus Quantity: 242,945 pacemakers [updated 3/20/2023] Lot/code info: 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 7630801 7630802 7630803 7630804 7630805 7630806 7630807 7630808 7630810 7630811 7630812 7630813 7630814 7630815 7630816 7630817 7630819 7630820 7630821 7630822 7630823 7630824 7630825 7630828 7630829 7630831 7630832 7630833 7630854 7630856 7630858 7630859 7630860 7630862 7630863 7630864 7630865 7630866 7630867 7630868 7630869 7630870 7630871 7630872 7630873 7630874 7630875 7630876 7630877 7630878 7630879 7630880 7630881 7630882 7630883 7630884 7630885 7630886 7630887 7630888 7630889 7630890 7630891
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.