FDA Device recall Z-0115-2017
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257…
- FDA Device
- Class I
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class I recall of Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257… 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-0115-2017 |
| 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
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR, Model No. CD2231-40, CD2231-40Q. Fortify ST DR, Model No. CD2241-40, CD-2241-40Q, CD2263-40, CD2363-40C, CD2363-40Q. Fortify Assura DR, Model No. CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q. 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 | Serial 607591 607592 607593 607594 607595 607596 607597 607598 607599 607600 607801 607802 607803 607804…Serial 607591 607592 607593 607594 607595 607596 607597 607598 607599 607600 607801 607802 607803 607804 607805 607806 607807 607808 607809 607810 607811 607812 607813 607814 607815 607816 607817 607818 607819 607820 607911 607912 607913 607914 607915 607916 607917 607918 607919 607920 607921 607922 607923 607924 607925 607927 607928 607929 607930 608221 608222 608223 608224 608225 608226 608227 608228 608229 608230 608231 608232 608233 608234 608235 608236 608237 608238 608239 608240 608241 608242 608243 608244 608245 608246 608247 608248 608249 608250 608391 608392 608393 608394 608395 608396 608397 608398 608399 608400 608401 608402 608403 608404 608405 608406 608407 608408 608409 608410 608531 608532 608533 608534 608535 608536 608537 608538 608539 608540 608541 608542 608543 608544 608545 608546 608547 608548 608549 608550 608671 608672 608673 608674 608675 |
|---|
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-0115-2017%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.