Boston Scientific Corporation: ACCOLADE DR SL (Model L301)

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: 32,695 units Lot/code info: GTIN 00802526558924, Serial Numbers: 100056, 100092, 100111, 100120, 100122, 100125, 100127, 100134, 100136, 100137, 100142, 100144, 100147, 100154, 100156, 100160, 100161, 100162, 100168, 100177, 100179, 100183, 100184, 100185, 100190, 100192, 100200, 100206, 100207, 100214, 100217, 100224, 100226, 100227, 100230, 100231, 100234, 100235, 100236, 100237, 100238, 100246, 100253, 100255, 100258, 100261, 100268, 100269, 100277, 100279, 100284, 100285, 100288, 100291, 100293, 100299, 100302, 100303, 100304, 100307, 100313, 100316, 100323, 100326, 100334, 100337, 100341, 100342, 100344, 100345, 100353, 100355, 100356, 100359, 100366, 100368, 100373, 100374, 100377, 100388, 100389, 100391, 100394, 100396, 100399, 100402, 100411, 100419, 100421, 100426, 100428, 100429, 100437, 100440, 100441, 100445, 100447, 100448, 100449, 100450, 100454, 100456, 100457, 100460, 100467, 100468, 100469, 100472, 100474, 100475, 100491, 100493, 100497, 100498, 100499, 100501, 100502, 100503, 100505, 100507, 100509, 100510, 100511, 100520, 100521, 100530, 100532, 100542, 100543, 100548, 100552, 100557, 100560, 100562, 100565, 100568, 100569, 100571, 100572, 100573, 100587, 100597, 100610, 100611, 100613, 100617, 100622, 100627, 100629, 100630, 100641, 100653, 100665, 100666, 100667, 100668, 100669, 100671, 100673, 100675, 100677, 100681, 100682, 100683, 100687, 100690, 100691, 100692, 100696, 100697, 100701, 100702, 100703, 100705, 100706, 100710, 100716, 100717, 100718, 100719, 100723, 100724, 100726,

UPC codes

00802526558924

Source

Official record: FDA (Device enforcement) ↗

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