Boston Scientific Corporation: Model Number S722, ALTRUA 2 DR EL Pacemaker

Hazard

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Details from the source

Reason for recall: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). Distribution: Worldwide Quantity: 3376 units Lot/code info: GTIN 00802526559372, Serial numbers: 100037, 100039, 100040, 100041, 100042, 100052, 100066, 100067, 100068, 100070, 100071, 100072, 100073, 100075, 100076, 100077, 100080, 100081, 700442, 700445, 700447, 700448, 700452, 700455, 700470, 700486, 700541, 700554, 700568, 700569, 700589, 700636, 700666, 702537, 702548, 702681, 702731, 702760, 702763, 702766, 702767, 702773, 702775, 702900, 702902, 702903, 702911, 702930, 704458, 704459, 704521, 707526, 707529, 708164, 708180, 708183, 708252, 708264, 708427. GTIN 00802526576515, Serial numbers: 100002, 100003, 100004, 100006, 100008, 100009, 100010, 100011, 100012, 100014, 100015, 100016, 100017, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100029, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100038, 100044, 100046, 100047, 100048, 100049, 100050, 100053, 100054, 100055, 100056, 100057, 100059, 100060, 100061, 100064, 100078, 100082, 100083, 100084, 100086, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700008, 700009, 700011, 700012, 700013, 700014, 700016, 700017, 700018, 700019, 700020, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700041, 700042, 700043, 700044, 700045, 700046, 700047, 700048, 700049, 700050, 700052, 700053, 700054, 700055, 700056, 700057, 700058, 700059, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700068, 700069, 700070, 700071, 700072, 70

UPC codes

00802526559372, 00802526576515, 00802526578113

Source

Official record: FDA (Device enforcement) ↗

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