Boston Scientific Corporation: PROPONENT SR SL (Model L200)

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: 1380 units Lot/code info: GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 710789, 710790, 710824, 710825, 710831, 710889, 710905, 710907, 710910, 710916, 710931, 710954, 710980, 711315, 711412, 711640, 711655, 714062, 714644, 714688, 714708, 715328, 717903, 717931, 717934, 717941, 717948, 717950, 717951, 717965, 717976, 717981, 717982, 717992, 718007, 718009, 718138, 718522, 718780, 718783, 718937, 720309, 720504, 720556, 720597, 720650, 721983, 721991, 722012, 722438, 722565, 722689, 722724, 722756, 722967, 723456, 724170, 724319, 724398, 724404, 724485, 724623, 725175, 72

UPC codes

00802526559020, 00802526576362, 00802526578007

Source

Official record: FDA (Device enforcement) ↗

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