Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
From the FDA notice · Read the official notice ↗ · All Medtronic recalls
What to do
The agency's notice has the remedy and who to contact.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 6591 units
- Illnesses reported
- None reported
- Manufactured in
- 8200 Coral Sea St Ne, Mounds View, MN, United States
- Classification
- Class II
- Recall number
- Z-0726-2026
In the FDA's words
- Description
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. UDI-DI: 00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068, 00763000744694; Serial Numbers: EVS600036S EVS600038S EVS600034S EVS600044S EVS600033S EVS600048S EVS600049S EVS600139S EVS600039S EVS600040S EVS600056S EVS600140S EVS600075S EVS600149S EVS600060S EVS600157S EVS600032S EVS600154S EVS600161S EVS600045S EVS600050S EVS600150S EVS600061S EVS600064S EVS600065S EVS600178S EVS600201S EVS600058S EVS600180S EVS600168S EVS600156S EVS600057S EVS600212S EVS600164S EVS600155S EVS600167S EVS600134S EVS600209S EVS600177S EVS600170S EVS600055S EVS600220S EVS600236S EVS600141S EVS600166S EVS600254S EVS600211S EVS600234S EVS600142S EVS600357S EVS600353S EVS600210S EVS600354S EVS600218S EVS600364S EVS600348S EVS600374S EVS600369S EVS600384S EVS600343S EVS600207S EVS600371S EVS600389S EVS600053S EVS600135S EVS600367S EVS600206S EVS600349S EVS600344S EVS600408S EVS600365S EVS600407S EVS600052S EVS600203S EVS600350S EVS600411S EVS600412S EVS600051S EVS600397S EVS600400S EVS600423S EVS600165S EVS600390S EVS600351S EVS600370S EVS600641S EVS600368S EVS600216S EVS600382S EVS600199S EVS600208S EVS600399S EVS600380S EVS600221S EVS600415S EVS600073S EVS600205S EVS600159S EVS600239S EVS600179S EVS600642S EVS600671S EVS600646S EVS600648S EVS600658S EVS600660S EVS600649S EVS600651S EVS600669S EVS600657S EVS600643S EVS600672S EVS600670S EVS600681S EVS600680S EVS600676S EVS600683S EVS600679S EVS600673S EVS600686S EVS600653S EVS600654S EVS600665S EVS600741S EVS600743S EVS600745S EVS600153S EVS600650S EVS600663S EVS600656S EVS600666S EVS600675S EVS600281S EVS600095S EVS600096S EVS600011S EVS600097S EVS600255S EVS600074S EVS600085S EVS600247S EVS600252S EVS600094S EVS600086S EVS600266S EVS600267S EVS600502S EVS600314S EVS600277S EVS600303S EVS600304S EVS600305S EVS600272S EVS600273S EVS600012S EVS600013S EVS600015S EVS600016S EVS600027S EVS600315S EVS600313S EVS600316S EVS600317S EVS600318S EVS600571S EVS600572S EVS600307S EVS600308S EVS600573S EVS600575S EVS600612S EVS600614S EVS600014S EVS600028S EVS600071S EVS600078S EVS600098S EVS600248S EVS600251S EVS600306S EVS600327S EVS600271S EVS600069S EVS600332S EVS600378S EVS600381S EVS600375S EVS600376S EVS600377S EVS600393S EVS600418S EVS600246S EVS600420S EVS600421S EVS600324S EVS600325S EVS600482S EVS600483S EVS600484S EVS600488S EVS600322S EVS600263S EVS600335S EVS600340S EVS600373S EVS600485S EVS600496S EVS600256S EVS600500S EVS600543S EVS600553S EVS600481S EVS600487S EVS600630S EVS600631S EVS600329S EVS600510S EVS600503S EVS600529S EVS600513S EVS600385S EVS600524S EVS600525S EVS600526S EVS600262S EVS600486S EVS600326S EVS600495S EVS600530S EVS600527S EVS600511S EVS600520S EVS600554S EVS600548S EVS600512S EVS600521S EVS600504S EVS600531S EVS600541S EVS600591S EVS600597S EVS600598S EVS600507S EVS600600S EVS600522S EVS600093S EVS600532S EVS600557S EVS600558S EVS600560S EVS600542S EVS600577S EVS600088S EVS600337S EVS600338S EVS600339S EVS600089S EVS600568S EVS600092S EVS600579S EVS600090S EVS600547S EVS600576S EVS600616S EVS600556S EVS600559S EVS600258S EVS600259S EVS600310S EVS600312S EVS600517S EVS600623S EVS600319S EVS600618S EVS600336S EVS600311S EVS600334S EVS600498S EVS600341S EVS600352S EVS600491S EVS600492S EVS600494S EVS600342S EVS600489S EVS600567S EVS600611S EVS600099S EVS600268S EVS600501S EVS600100S EVS600265S EVS600269S EVS600270S EVS600320S EVS600549S EVS600550S EVS600619S EVS600620S EVS600633S EVS600635S EVS600551S EVS600288S EVS600569S EVS600570S EVS600638S EVS600639S EVS600640S EVS600505S EVS600518S EVS600561S EVS600566S EVS600629S EVS600555S EVS600534S EVS600578S EVS600580S EVS600720S EVS600699S EVS600700S EVS600701S EVS600702S EVS600704S EVS600705S EVS600706S EVS600707S EVS600708S EVS600709S EVS600710S EVS600711S EVS600712S EVS600715S EVX600203S EVX600204S EVX600205S EVX600199S EVX600195S EVX600250S EVX600246S EVX600197S EVX600251S EVX600255S EVX600257S EVX600230S EVX600253S EVX600256S EVX600258S EVX600264S EVX600277S EVX600278S EVX600297S EVX600307S EVX600265S EVX600427S EVX600202S EVX600298S EVX600233S EVX600238S EVX600313S EVX600222S EVX600455S EVX600456S EVX600457S EVX600458S EVX600459S EVX600468S EVX600469S EVX600471S EVX600243S EVX600252S EVX600260S EVX600210S EVX600194S EVX600448S EVX600227S EVX600472S EVX600473S EVX600211S EVX600225S EVX600462S EVX600432S EVX600434S EVX600494S EVX600302S EVX600242S EVX600425S EVX600304S EVX600201S EVX600228S EVX600231S EVX600236S EVX600287S EVX600234S EVX600235S EVX600247S EVX600283S EVX600454S EVX600436S EVX600284S EVX600424S EVX600479S EVX600296S EVX600446S EVX600495S EVX600276S EVX600518S EVX600943S EVX600944S EVX600945S EVX600946S EVX600947S EVX600237S EVX600218S EVX600523S EVX600244S EVX600292S EVX600215S EVX600443S EVX600453S EVX600486S EVX600461S EVX6
- Hazard
- There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
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