Z-1351-2020Class II

Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C...

Name: Z-1351-2020 Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C...
Creator: St Jude Medical, Cardiac Rhythm Management Division
Published: 2020-01-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-01-22 / Terminated

FDA source

St Jude Medical, Cardiac Rhythm Management Division began a recall of Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045)... on 2020-01-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1351-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-22
Posted: 2020-02-24
Terminated: 2020-12-17
Recalling firm: Abbott Medical
Product: 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
Product code: NVZ Pulse Generator, Permanent, Implantable
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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1351-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1351-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-24

Product code NVZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)