Boston Scientific Corporation: ACCOLADE DR EL (Model L321)

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: 7,488 units Lot/code info: GTIN 00802526558986, Serial Numbers: 100004, 100005, 100033, 100051, 100054, 100058, 100075, 100076, 100092, 100106, 100107, 100109, 100111, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100125, 100127, 100128, 100130, 100132, 100133, 100134, 100135, 100137, 100141, 100144, 100147, 100149, 100150, 100158, 100159, 100160, 100161, 100162, 100164, 100165, 100168, 100169, 100173, 100175, 100177, 100178, 100179, 100181, 100182, 100184, 100186, 100187, 100188, 100190, 100191, 100193, 100195, 100197, 100199, 100202, 100206, 100209, 100212, 100215, 100220, 100223, 100227, 100228, 100231, 100233, 100234, 100235, 100236, 100237, 100238, 100239, 100241, 100242, 100243, 100244, 100245, 100246, 100248, 100249, 100250, 100251, 100253, 100255, 100257, 100259, 100260, 100261, 100262, 100265, 100266, 100267, 100273, 100274, 100277, 100280, 100281, 100283, 100286, 100287, 100288, 100289, 100291, 100294, 100295, 100299, 100300, 100337, 100339, 100341, 100344, 100348, 100350, 100351, 100353, 100354, 100355, 100357, 100363, 100366, 100367, 100369, 100371, 100374, 100376, 100378, 100380, 100381, 100384, 100387, 100390, 100395, 100447, 100471, 100482, 100485, 100486, 100496, 100502, 100504, 100509, 100512, 100516, 100518, 100519, 100528, 100532, 100540, 100544, 100547, 100552, 100565, 100572, 100573, 100575, 100577, 100578, 100581, 100583, 100585, 100589, 100592, 100597, 100601, 100603, 100610, 100614, 100741, 100748, 100755, 100761, 100762, 100766, 100771, 100774, 100790, 100791, 100798,

UPC codes

00802526558986, 00802526558993

Source

Official record: FDA (Device enforcement) ↗

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