FDA Device recall Z-2326-2018
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904 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-2326-2018 |
| 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, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
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 #: 1015752 730063 739101 737664 1100971 1220399 1220292 1220290 1220402 1220289 1220397 1220296 790…Serial #: 1015752 730063 739101 737664 1100971 1220399 1220292 1220290 1220402 1220289 1220397 1220296 790402 1220298 1220297 1220302 1220398 1220300 1220304 1011008 1045234 727133 727125 1015722 769238 782698 806935 1203620 824778 1194681 1194692 1142920 1142348 1142916 761491 763173 768968 746500 773404 790396 807191 805967 761487 769242 749537 761680 720899 788660 769286 782672 761268 784460 825005 717555 736459 810157 805939 815815 824979 790367 725376 740816 816153 805857 761277 810470 761544 795775 787617 810502 782965 782595 716018 810139 795160 714115 763261 759507 760107 756103 761270 746528 751518 759307 752216 729982 739033 746540 784581 739855 733125 715856 746556 721983 810191 782611 1045235 784269 720881 717536 720903 769225 810648 1193445 810477 768943 714157 815756 715461 1043121 720930 715656 1000812 714194 1043232 815769 1047169 769275 810506 782683 |
|---|
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-2326-2018%22
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