United StatesPacemaker models including ACCOLADE SR SL (Model L300) and 26 additional ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 dual‑chamber pacemakers and VISIONIST and VALITUDE CRT‑P devices are affected and can be identified by model numbers, the GTIN 00802526558900 and the listed serial numbers. They were recalled because software to enhance Safety Architecture is available and is designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state.
What's being recalled
ACCOLADE SR SL (Model L300)
ACCOLADE DR SL (Model L301)
ACCOLADE SR SL MRI (Model L310)
ACCOLADE DR SL MRI (Model L311)
ACCOLADE DR EL (Model L321)
ACCOLADE DR EL MRI (Model L331)
PROPONENT SR SL (Model L200)
PROPONENT DR SL (Model L201)
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Model Number L210 PROPONENT SR SL Pacemaker
Model Number L211 PROPONENT DR SL MRI Pacemaker
Model Number L221 PROPONENT DR EL Pacemaker
Model Number L231, PROPONENT DR EL MRI Pacemaker
Model Number L100, ESSENTIO SR SL Pacemaker
Model Number L101, ESSENTIO DR SL Pacemaker
And 12 more products.
Recalling firm: Boston Scientific Corporation, Saint Paul, MN, United States.
How to identify it
GTIN 00802526558900, Serial Numbers: 464190, 464192, 464197, 464228, 464229, 464230, 464238, 464258, 464279, 464295, 464296, 464316, 464321, 464358, 464360, 464361, 464362, 464363, 464369, 464371, 464378, 464383, 464384, 464392, 464393, 464398, 464400, 464406, 464408, 464409, 464410, 464411, 464414, 464425, 464427, 464430, 464432, 464435, 464437, 464441, 464442, 464443, 464451, 464455, 464456, 464466, 464469, 464474, 464480, 464484, 464485, 464487, 464488, 464489, 464496, 464502, 464503, 464504, 464507, 464520, 464529, 464531, 464534, 464538, 464544, 464547, 464551, 464556, 464558, 464560, 464566, 464571, 464577, 464583, 464585, 464586, 464587, 464588, 464591, 464592, 464604, 464608, 464611, 464617, 464623, 464635, 464637, 464639, 464642, 464643, 464653, 464660, 464662, 464664, 464665, 464667, 464668, 464681, 464683, 464685, 464692, 464697, 464698, 464699, 464700, 464706, 464707, 464708, 464712, 464715, 464720, 464721, 464726, 464730, 464734, 464736, 464738, 464740, 464741, 464743, 464744, 464745, 464746, 464749, 464750, 464751, 464754, 464758, 464761, 464766, 464767, 464771, 464772, 464774, 464775, 464776, 464778, 464779, 464781, 464784, 464787, 464788, 464795, 464796, 464797, 464800, 464805, 464806, 464807, 464810, 464811, 464821, 464824, 464825, 464828, 464830, 464831, 464833, 464837, 464838, 464843, 464848, 464852, 464857, 464858, 464859, 464860, 464870, 464883, 464891, 464893, 464899, 464900, 464901, 464902, 464926, 465020, 465058, 465118, 465121, 465147, 465171, 465179, 465187, 465191, 465196, 465203, 465204, 465205, 465215, 465217, 465219, 465228, 465230, 465231, 465244, 465254, 465255, 465256, 465267, 465269, 465272, 465275, 465278, 465280, 465291, 465295, 465298, 465310, 465313, 465315, 465323, 465324, 465325, 465327, 465331, 465333, 465337, 465338, 465339, 465342, 465346, 465349, 465350, 465355, 465356, 465360, 465363, 465365, 465368, 465369, 465374, 465375, 465379, 465388, 465390, 465393, 465395, 465405, 465413, 465500, 465673, 465747, 465752, 465830…
The 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).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada