FDA Device recall Z-2324-2018
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846 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-2324-2018 |
| 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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/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 #: 1005250 1100829 1013442 1099070 1099529 1005562 1051389 1059113 1005929 1005557 1003819 1003806…Serial #: 1005250 1100829 1013442 1099070 1099529 1005562 1051389 1059113 1005929 1005557 1003819 1003806 1005547 1003851 1003825 1005545 1005936 1003843 1005964 1005252 1005934 1003833 1003852 1005931 1051430 1005260 1005963 1005949 1005950 1005256 1003835 1005946 1003815 1005954 1005966 1005958 1005264 1005941 1099534 1003820 1005262 1099517 1051417 1051415 1051408 1043032 1051434 1051428 1051411 1051423 1059110 1051387 1005553 1100826 1051410 1005267 1003844 1005544 1059097 1003816 1059111 1051394 1059105 1051398 1059112 1051385 1043026 1059108 1099349 1051422 1051407 1085829 1085833 1085837 1085831 1051309 1059118 1005566 1003803 1043020 1003805 1099341 1043023 1005953 1099523 1013447 1099051 1099057 1005944 1085835 1099528 1099060 1005940 1051402 1005259 1043021 1059117 1013443 1043027 1051319 1003846 1003826 1051397 1005935 1013449 1005565 1085832 1003807 1099532 1100823 |
|---|
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-2324-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.