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
- Recall Initiated
- January 22, 2020
- Terminated
- December 17, 2020
- Recall Number
- Z-1351-2020
- Quantity
- 256
- Firm Location
- Sylmar, CA
Reason for Recall
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.
Distribution
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 / Code Info
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
Root Cause
Other
Action Taken
Starting on 01/22/20, Important Medical Device Correction notices were hand delivered by the recalling firm's sales representatives. Physicians were informed that the recalling firm developed a software patch for programmers which restores wireless RF communication capability in affected devices. Device explant is not required for the update. The recalling firm will assist in updating programmer software and restoring wireless RF communication for affected devices. Correction notices recommend working with firm representatives to help correct affected devices during the patient's next regularly scheduled visit. Physicians were asked to complete and return the Acknowledgement Forms and to retain the correction notice. Customers with additional questions were encouraged to call Technical Support at 1-800-722-3774.