FDA Device recall Z-0004-2018
Unify, Model Numbers: CD3231-40 and CD3231-40Q
- FDA Device
- Class I
- terminated
- Published 2017-10-18
On 2017-10-18 the FDA classified a Class I recall of Unify, Model Numbers: CD3231-40 and CD3231-40Q by St Jude Medical, citing the device may exhibit premature battery depletion.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0004-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-08-28 |
| Published | 2017-10-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
Reason
The device may exhibit premature battery depletion.
Identifiers
| code_info | Serial Numbers: 591144 617036 625707 7008535 629874 641260 627997 638226 1017774 1043239 1018436 1002811 7…Serial Numbers: 591144 617036 625707 7008535 629874 641260 627997 638226 1017774 1043239 1018436 1002811 7012648 7005554 616343 593297 595815 760130 607175 633948 717548 1003642 721997 795698 747687 638422 592934 637368 745438 743874 739328 805873 788997 754856 605200 593643 618895 607352 622756 622614 614876 790329 613202 613336 761682 606830 605798 607041 603157 635630 640359 746514 807431 795684 1043148 597053 628368 612783 633942 624009 601128 595811 717522 594212 1018396 1000850 1001632 752494 747710 1045252 1045256 805934 611488 629857 618366 595417 630122 633371 609158 632187 7013706 632292 7013927 7005155 648250 7021934 7008561 7005346 641258 7015283 642552 643189 1043139 810204 1001652 825628 7012674 7008095 1000251 1043273 7030287 715845 1045234 613757 7009099 7009100 7008909 715847 715555 1010487 1011017 784541 632854 721993 7012638 720848 7019523 648487 702 |
|---|
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-0004-2018%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.