Boston Scientific Corporation: PROPONENT DR SL (Model L201)

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: 2,426 units Lot/code info: GTIN 00802526559044, Serial Numbers: 760356, 760366, 760367, 760404, 760409, 760412, 760441, 760443, 760500. GTIN 00802526576379, Serial numbers: 767280. GTIN 00802526559051, Serial numbers: 767088, 799586. GTIN 00802526576379, Serial Numbers: 100164, 100165, 100174, 100186, 100243, 100767, 100800, 723990, 724576, 724581, 724583, 724597, 724612, 724614, 724616, 724619, 724620, 724640, 724644, 724645, 724654, 724658, 724663, 724664, 724665, 724666, 724670, 724671, 724698, 724700, 724701, 724703, 724724, 724731, 724732, 724733, 724747, 724752, 724753, 724756, 724765, 724766, 724768, 724770, 724773, 724774, 724781, 724785, 724786, 724797, 724807, 724809, 724810, 724811, 724812, 724813, 724814, 724815, 724816, 724817, 724820, 724823, 724826, 724829, 724833, 724869, 724950, 724958, 724974, 724975, 724977, 724980, 724981, 725647, 725651, 725705, 725711, 725734, 725742, 725749, 725774, 725775, 725787, 726012, 726021, 726027, 726030, 726077, 726083, 726100, 726115, 726129, 726151, 726160, 726176, 726178, 726197, 726202, 726255, 726268, 726278, 726385, 726393, 726425, 726489, 726529, 726546, 726552, 726563, 726569, 726576, 726580, 726596, 726600, 726637, 726650, 726708, 726710, 726717, 726718, 726723, 726733, 726736, 726747, 726791, 726806, 726822, 727141, 727202, 733301, 734188, 735930, 736415, 736900, 737251, 737289, 737295, 737979, 737999, 738250, 738466, 738516, 738537, 738571, 738601, 738617, 738692, 738706, 739854, 739903, 739919, 739927, 739980, 740026, 740088, 740090, 740099,

UPC codes

00802526559044, 00802526576379, 00802526559051, 00802526576874, 00802526578014

Source

Official record: FDA (Device enforcement) ↗

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