Ellipse recall
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36…
Why was Ellipse recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36…
- Recalling firm
- St Jude Medical, Cardiac Rhythm Management Division
- Quantity
- 256
- 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
- Recall date
- March 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)