Boston Scientific Corporation: Model Number L221 PROPONENT DR EL 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: 3592 units Lot/code info: GTIN 00802526578045, Serial Numbers: 723080, 723248, 725570, 729255. GTIN 00802526559129. Serial Numbers: 732639. GTIN 00802526576416, Serial numbers: 100156, 100157, 100167, 100180, 100185, 100247, 100254, 100263, 100268, 100272, 100278, 100279, 100282, 100293, 100296, 100302, 100304, 100305, 100306, 100308, 100314, 100315, 100332, 100335, 100336, 100453, 702524, 702763, 703141, 703183, 703341, 703490, 704875, 705065, 705069, 706965, 707072, 707119, 707355, 707474, 707499, 707999, 708019, 708170, 708229, 709024, 712293, 712330, 712402, 712408, 712424, 712437, 712517, 713937, 714362, 714643, 714710, 714836, 714847, 715761, 715890, 716146, 716435, 716731, 717103, 717117, 717537, 718007, 718062, 718114, 718137, 718139, 718301, 718312, 719571, 719630, 719635, 719637, 719653, 719835, 720752, 720838, 721277, 721298, 721511, 721604, 722560, 723084, 723234, 723279, 723335, 723486, 723491, 723494, 723498, 723509, 723529, 723557, 723559, 723562, 723573, 723625, 724616, 724666, 724696, 724709, 724782, 724819, 724838, 724846, 724853, 724857, 724890, 724914, 725181, 725182, 725183, 725184, 725185, 725186, 725187, 725188, 725189, 725190, 725586, 725603, 725604, 725605, 725607, 725608, 725609, 725610, 725727, 725792, 725801, 726384, 726419, 726545, 726800, 726801, 726878, 727128, 727172, 727178, 727236, 727242, 727255, 727257, 727262, 727263, 727268, 727271, 727292, 727315, 727323, 727335, 727346, 727376, 727378, 727379, 727382, 728093, 728135, 728139, 728153, 728301, 728324, 728381, 72865

UPC codes

00802526578045, 00802526559129, 00802526576416

Source

Official record: FDA (Device enforcement) ↗

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