Boston Scientific Corporation: Model Number L101, ESSENTIO DR SL 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: 22,714 units Lot/code info: GTIN 00802526559174, Serial Numbers: 100547, 100752, 100822, 100843, 100852, 100853, 100857, 100863, 100865, 100866, 100868, 100871, 100874, 100879, 100883, 100884, 100889, 100891, 100892, 100893, 100897, 100900, 100914, 100915, 100916, 100919, 100923, 100925, 100927, 100928, 100931, 100932, 100938, 100941, 100942, 100944, 100948, 100949, 100952, 100955, 100956, 100957, 100962, 100969, 100970, 100972, 100973, 100980, 100981, 100982, 100985, 100986, 100988, 100989, 100990, 100991, 100993, 100995, 100996, 101000, 101002, 101003, 101004, 101006, 101012, 101014, 101015, 101016, 101017, 101020, 101021, 101022, 101024, 101025, 101033, 101036, 101037, 101042, 101044, 101048, 101050, 101052, 101053, 101059, 101061, 101063, 101067, 101073, 101074, 101075, 101076, 101087, 101090, 101092, 101093, 101096, 101097, 101098, 101105, 101106, 101108, 101109, 101110, 101111, 101113, 101120, 101125, 101126, 101127, 101129, 101130, 101131, 101132, 101136, 101138, 101141, 101144, 101148, 101149, 101154, 101155, 101157, 101158, 101170, 101174, 101177, 101179, 101180, 101184, 101185, 101186, 101187, 101190, 101200, 101202, 101207, 101208, 101214, 101221, 101223, 101224, 101225, 101228, 101229, 101234, 101235, 101236, 101238, 101242, 101244, 101245, 101246, 101249, 101258, 101261, 101262, 101271, 101272, 101274, 101283, 101286, 101297, 101299, 101303, 101309, 101313, 101314, 101315, 101316, 101318, 101322, 101328, 101334, 101336, 101348, 101354, 101359, 101361, 101372, 101379, 101380, 101382, 101388,

UPC codes

00802526559174

Source

Official record: FDA (Device enforcement) ↗

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