Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Reason for recall: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. Distribution: US Nationwide distribution including in the states of 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. OUS: Pending Quantity: 10,610 units Lot/code info: UDI: 05415067034472/ Serial Numbers: 524933 524932 1301967 1301958 1301969 1301971 1301953 1301965 1301952 1301966 1301916 1301963 1301912 1301968 524931 1304777 1301964 1304509 1304507 1302859 1304519 1304791 1304828 1304815 1304821 1304823 1304824 1304522 1304822 1304820 1304829 1304805 1304835 1304836 1304834 1304841 1304837 1304788 1304797 1304802 1304799 1304845 1304854 1304846 1304857 1304852 1304847 1304858 1304868 1304866 1304862 1304870 1304864 1304859 1304856 1304899 1304945 1304959 1304918 1304957 1304906 1304949 1304933 1304911 1304960 1304958 1304903 1304927 1304908 1304919 1304901 1304968 1304962 1304920 1304997 1304931 1305002 1305007 1304884 1304993 1304977 1305000 1304991 1304998 1304994 1304996 1304956 1304982 1304978 1304989 1304990 1304980 1304983 1304984 1304981 1304988 1305018 1305026 1305023 1305010 1305034 1305012 1305005 1305014 1305061 1305083 1305052 1305011 1305084 1305045 1305044 1305040 1305047 1305041 1305053 1305060 1305057 1305043 1305042 1305046 1305054 1305079 1305076 1305068 1305088 1305086 1305056 1305077 1305072 1305069 1305070 1305071 1305074 1305024 1305033 1305067 1305080 1305073 1305062 1305021 1305085 1305173 1305171 1305183 1305172 1305170 1305182 1305236 1305178 1305227 1305176 1305211 1305174 1305180 1305223 1305234 1305230 1305204 1305181 1305224 1305179 1305237 1305203 1305218 1305177 1305175 1305196 1305184 1305215 1305208 1305209 1305219 1305229 1305210 1305217 1305222 1305059 1305442 1305467 1305441 1305435 1305443 1305448 13
05415067034472
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.