Boston Scientific Corporation: Model Number L211 PROPONENT DR 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: 106,536 units Lot/code info: GTIN 00802526559105, Serial Numbers: 296409, 658411. GTIN 00802526576409, Serial Numbers: 431535. GTIN 00802526578038, Serial Numbers: 251896, 375153, 396268. GTIN 00802526559105, Serial Numbers: 100009, 100020, 100022, 100024, 100028, 100030, 100031, 100037, 100038, 100039, 100043, 100046, 100047, 100048, 100049, 100052, 100053, 100058, 100061, 100063, 100066, 100068, 100075, 100077, 100078, 100080, 100083, 100087, 100090, 100091, 100095, 100097, 100098, 100106, 100113, 100122, 100125, 100127, 100130, 100131, 100132, 100133, 100143, 100145, 100156, 100158, 100163, 100166, 100167, 100168, 100170, 100172, 100174, 100175, 100179, 100187, 100188, 100191, 100194, 100198, 100206, 100207, 100209, 100210, 100213, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100230, 100231, 100237, 100244, 100246, 100247, 100248, 100249, 100268, 100269, 100270, 100271, 100275, 100280, 100281, 100290, 100291, 100309, 100316, 100334, 100390, 100395, 100398, 100427, 100430, 100438, 100446, 100460, 100462, 100478, 100482, 100487, 100488, 100493, 100497, 100505, 100509, 100510, 100513, 100514, 100516, 100522, 100527, 100529, 100532, 100537, 100542, 100551, 100555, 100559, 100565, 100567, 100571, 100576, 100578, 100580, 100584, 100585, 100592, 100594, 100598, 100600, 100601, 100606, 100612, 100613, 100617, 100618, 100619, 100621, 100622, 100623, 100631, 100634, 100638, 100643, 100647, 100648, 100649, 100651, 100652, 100653, 100659, 100660, 100668, 100669, 100670, 100672,

UPC codes

00802526559105, 00802526576409, 00802526578038

Source

Official record: FDA (Device enforcement) ↗

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