FDA Device recall Z-0117-2017
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fort…
- FDA Device
- Class I
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class I recall of Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fort… by St Jude Medical, citing st Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature batt….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0117-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-10-10 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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. 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
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Identifiers
| code_info | 651567 651568 651569 651571 651572 651573 651574 651575 652141 652143 652144 652145 652147 652148 652150…651567 651568 651569 651571 651572 651573 651574 651575 652141 652143 652144 652145 652147 652148 652150 652311 652312 652313 652314 652315 652316 652317 652318 652319 652320 1006608 1006609 1006610 1006611 1006612 1006613 1006614 1006615 1006616 1006617 1006618 1006619 1006620 1006621 1006622 1006623 1006624 1006625 1006626 1006627 1006628 1006629 1006630 1006631 1006633 1006634 1006635 1006636 1006637 1006638 1006639 1006640 1006641 1006642 1006643 1006644 1017620 1017621 1017622 1017623 1017624 1017625 1017626 1017628 1017629 1017630 1017631 1017632 1017633 1017634 1017635 1017636 1017637 1017638 1017639 1017640 1017641 1017642 1017643 1017644 1017645 1017646 1017647 1017648 1017649 1017651 1017652 1017654 1017655 1017656 1017657 1017658 1017659 1017660 1017661 1017662 1017663 1017664 1017665 1017666 1017667 1028491 1028492 1028493 1033490 1033491 1033492 1033493 1033494 |
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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-0117-2017%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.