FDA Device recall Z-2321-2018
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623 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-2321-2018 |
| 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
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
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 #: 1045139 1035604 1045175 1050029 1035597 1062191 1064271 1064263 1064272 1032866 1064264 1086176…Serial #: 1045139 1035604 1045175 1050029 1035597 1062191 1064271 1064263 1064272 1032866 1064264 1086176 1115280 1018022 842863 1086165 1035596 842871 1062207 1062214 1044143 1062196 1050028 1050023 1035567 1044127 1045141 1062216 1045177 1032860 1086168 1062215 1064274 1062198 1106554 1035615 1044125 1062212 1086160 1051918 1045150 1045145 1018026 1086161 1044134 1032871 1026649 1045148 1045174 1035588 1044150 1062219 1045151 1050020 1101094 1026650 1086177 1026645 1062230 1062226 1045147 1026648 1050027 1026646 1051911 1062227 1062202 1064261 1086184 1036577 1064252 1086181 1018017 1045152 1064268 1062218 1064276 1018020 1062206 1018008 842865 1032861 1051913 1106553 1051919 1064259 1032857 1064257 1062208 1044153 842868 1064275 1051903 1064254 1045165 1086175 1051906 1045143 1051908 1044115 1044147 1044119 1032862 1062205 1062213 1051914 1044124 1064267 1044120 1045159 104 |
|---|
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-2321-2018%22
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