Boston Scientific Corporation: Model Number L110, ESSENTIO SR SL MRI 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: 61,700 units Lot/code info: GTIN 00802526559204, Serial Numbers: 102163, 700197, 700207, 701035, 701546, 702086, 702129, 702195, 702303, 702316, 702343, 702530, 702612, 702615, 702619, 702715, 702745, 702802, 702807, 702833, 702840, 702844, 702871, 702872, 702890, 702891, 702898, 702912, 702918, 702925, 702930, 702931, 702966, 702974, 702979, 702991, 702999, 703010, 703035, 703047, 703053, 703058, 703065, 703069, 703090, 703099, 703101, 703122, 703124, 703136, 703142, 703147, 703150, 703152, 703173, 703177, 703191, 703199, 703240, 703241, 703247, 703252, 703261, 703297, 703306, 703326, 703339, 703348, 703353, 703376, 703380, 703417, 703420, 703450, 703452, 703453, 703460, 703510, 703511, 703535, 704093, 704200, 704263, 704341, 704480, 704580, 704656, 704661, 704678, 704679, 704703, 704726, 704755, 704769, 704802, 704812, 704813, 704815, 704817, 704820, 704823, 704839, 704849, 704869, 704872, 704875, 704895, 704898, 704900, 704915, 704926, 704938, 704945, 704956, 704986, 704998, 705007, 705010, 705020, 705038, 705054, 705119, 705200, 705372, 705557, 705934, 705951, 705974, 705989, 706005, 706129, 706340, 706579, 707685, 707751, 707758, 708308, 708404, 708490, 708804, 709351, 709443, 709847, 710013, 710082, 710117, 710287, 710329, 710336, 710378, 710403, 710463, 710478, 710565, 710567, 710607, 710608, 710612, 710623, 710655, 710687, 710697, 710720, 710729, 710731, 710748, 710749, 710750, 710752, 710761, 710763, 710768, 710821, 710870, 710877, 710878, 710884, 710889, 710890, 710898, 710901, 711141, 711142,

UPC codes

00802526559204

Source

Official record: FDA (Device enforcement) ↗

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