FDA Device recall Z-2327-2018
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944 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-2327-2018 |
| 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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
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 #: 1037182 1005203 1042043 1035639 1043218 1038138 1057760 1043082 1042007 1038370 1043174 1035637…Serial #: 1037182 1005203 1042043 1035639 1043218 1038138 1057760 1043082 1042007 1038370 1043174 1035637 1004332 1043052 1043193 1013295 1006465 1037200 1004314 1005220 1006461 1006445 1004293 1006495 1005191 1005222 1004302 1004329 1059129 1005200 1006447 1005214 1005195 1006472 1006452 1004307 1005228 1006507 1040448 1042005 1006480 1004324 1005219 1004310 1005206 1041981 1013287 1006485 1006456 1004309 1040418 1040482 1037151 1043051 1040431 1040424 1038164 1038165 1004308 1013319 1041966 1043214 1043050 1035638 1059136 1040472 1043206 1059150 1035648 1059146 1058494 1058489 1038173 1038192 1038176 1037183 1037144 1041952 1042035 1043046 1040439 1006500 1041945 1035672 1043038 1004322 1005223 1013324 1006491 1037209 1005216 1013300 1038145 1038377 1006475 1038183 1041949 1038372 1042021 1038185 1006443 1043065 1038166 1043201 1038171 1043057 1040489 1043060 1037171 1057759 |
|---|
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-2327-2018%22
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