FDA Device recall Z-2319-2018
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115 by St Jude Medical, citing the firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2319-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-16 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
Reason
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
Identifiers
| code_info | Serial #: 1000285 1025921 1039639 1007290 1047328 1049523 1049131 1039582 1081611 1000297 1039626 1034690…Serial #: 1000285 1025921 1039639 1007290 1047328 1049523 1049131 1039582 1081611 1000297 1039626 1034690 1045516 1039595 1050351 1073423 1035840 1013891 841883 1029377 843705 1089977 1059411 1032549 1096245 1025909 1035863 1018923 1024055 1041061 1026435 1007262 1024035 1067727 1089972 1034708 1018919 1018937 1065395 1018938 1007284 1007265 1000279 1007291 1030532 1073365 1000413 835226 1018871 1001270 1061428 1007294 1007275 1007269 1018926 1039632 1054258 1041039 843699 1077179 1084892 1054257 1032552 1030542 1034687 1039636 1034692 1032545 1034700 1015064 1067733 1045537 1018887 1015066 1049528 1053202 1053203 1026433 1000406 1007295 1061425 1030530 1053208 1035841 1089979 1073368 1007278 1047919 1039624 1084889 1025898 1062889 1059398 1032535 1045494 1059402 1034683 1044801 1039591 1024022 1044804 1044794 1065388 1018893 1052064 1050347 1050355 1052067 1062895 1065392 103 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2319-2018%22
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