FDA Device recall Z-0003-2018
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q
- FDA Device
- Class I
- terminated
- Published 2017-10-18
On 2017-10-18 the FDA classified a Class I recall of Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q by St Jude Medical, citing the device may exhibit premature battery depletion.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0003-2018 |
| 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
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage 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
Reason
The device may exhibit premature battery depletion.
Identifiers
| code_info | Serial Numbers: 1072092 1072099 1072095 610414 645754 645136 643980 719546 1176494 1176492 741560 810336 6…Serial Numbers: 1072092 1072099 1072095 610414 645754 645136 643980 719546 1176494 1176492 741560 810336 630647 643609 1161698 756189 736390 1161694 610846 733015 717362 788849 760066 7003656 622669 627017 627314 627696 610840 612400 741610 737607 705649 733310 738921 745376 754552 727079 725262 795252 789466 644370 607810 616517 625042 633253 625041 632204 642059 645143 629082 737580 789446 757787 709960 729842 755858 789525 625869 619824 619847 609493 646400 1065602 726655 739242 628904 741306 783806 717461 641150 648989 648991 643047 789524 617510 617804 1055329 630653 783829 1135487 7003653 608931 732969 643253 645123 608547 635511 635378 635896 727026 1135486 1072091 1072100 634489 635223 641344 645740 630638 611708 631908 631760 634635 640772 1022741 768797 1055327 749407 749320 1059014 748448 608532 633126 789450 1062336 733013 629481 1011653 645749 810063 782 |
|---|
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-0003-2018%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.