Medtronic, Inc.: Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

Hazard

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Details from the source

Reason for recall: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. Distribution: Worldwide - US Nationwide distribution. Quantity: 6591 units Lot/code info: 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 EVS60

UPC codes

00763000368470, 00763000368463, 00763000217907, 00763000217891, 00763000288068, 00763000744694

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.