FDAFDA · Food and drugs·Recall number Z-1351-2020
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330
Published March 4, 2020 · Recall initiated: January 22, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St Jude Medical, Cardiac Rhythm Management Division
- Distributor
- U.S.: WV, MS, TX, DE, OH, AZ, MI, NC, KY, WA, NY, CA, IN, MO, MD, NJ, FL, PA, OK. O.U.S.: United Kingdom, Turkey, Sweden, Spain, Portugal, Poland, Philippines, Pakistan, Norway, New Zealand, Netherlands, Japan, Italy, Hong Kong, Greece, Germany, France, Finland, Denmark, Canada, Belgium, Austria, Australia
- Lot
- Serial #: 1138400, 1138406, 1138391, 1138393, 1138403, 1138366, 1138387, 1138396, 1138386, 1138399, 1138374, 1138362, 1138368, 1138397, 1138401, 1138372, 1138375, 1138382, 1138380, 1138405, 1138377, 1138371, 1138390, 1138398, 1138367, 1138395, 1138389, 1138379, 1138370, 1138388, 1138364, 1138373, 1138385, 1138394, 1138381, 1138404, 1138392, 1138384, 1138376, 1138369, 1138365, 1138465, 1138620, 1138573, 1138590, 1138407, 1138408, 1138409, 1138411, 1138412, 1138413, 1138415, 1138416, 1138417, 1138419, 1138421, 1138422, 1138423, 1138424, 1138429, 1138431, 1138435, 1138436, 1138437, 1138441, 1138442, 1138467, 1138468, 1138469, 1138513, 1138612, 1138613, 1138615, 1138616, 1138617, 1138624, 1138626, 1138420, 1138587, 1138628, 1138510, 1138619, 1138428, 1138432, 1138433, 1138445, 1138446, 1138447, 1138449, 1138451, 1138455, 1138466, 1138470, 1138471, 1138474, 1138479, 1138488, 1138502, 1138507, 1138523, 1138538, 1138544, 1138548, 1138556, 1138575, 1138576, 1138577, 1138580, 1138597, 1138599, 1138608, 1138495, 1138503, 1138547, 1138563, 1138565, 1138581, 1138585, 1138543, 1138461, 1138501, 1138505, 1138508, 1138545, 1138546, 1138553, 1138557, 1138566, 1138567, 1138583, 1138588, 1138486, 1138489, 1138490, 1138491, 1138496, 1138497, 1138500, 1138542, 1138549, 1138550, 1138551, 1138555, 1138559, 1138560, 1138561, 1138564, 1138570, 1138579, 1138582, 1138586, 1138611, 1138618, 1138472, 1138482, 1138595, 1138589, 1138614, 1138434, 1138440, 1138443, 1138448, 1138450, 1138452, 1138453, 1138456, 1138457, 1138458, 1138459, 1138460, 1138462, 1138463, 1138464, 1138473, 1138476, 1138478, 1138480, 1138481, 1138514, 1138515, 1138516, 1138518, 1138519, 1138520, 1138521, 1138522, 1138524, 1138525, 1138526, 1138527, 1138528, 1138529, 1138530, 1138531, 1138532, 1138533, 1138534, 1138536, 1138537, 1138539, 1138540, 1138594, 1138596, 1138600, 1138601, 1138602, 1138603, 1138604, 1138605, 1138606, 1138607, 1138609, 1138622, 1138623, 1138631, 1138632, 1138633, 1138634, 1138635, 1138636, 1138487, 1138494, 1138552, 1138554, 1138610, 1138621, 1138493, 1138499, 1138504, 1138569, 1138627, 1138484, 1138571, 1138425, 1138426, 1138438, 1138439, 1138444, 1138498, 1138492, 1138509, 1138541, 1138558, 1138562, 1138568, 1138584, 1138578, 1138511, 1138512, 1138572, 1138591, 1138592, 1138593, 1138625, 1138485, 1138574, 1138430, 1138598, 1138402, 1138363, 1138454, 1138410, 1138383, 1138378, 1138517, 1138535, 1138418, 1138506, 1138414, 1138427, 1138475, 1138477, 1138483, 1138630
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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