FDA Device recall Z-2572-2014
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Car…
- FDA Device
- Class II
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class II recall of Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Car… by St Jude Medical Cardiac Rhythm Management Division, citing an anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2572-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-19 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | St Jude Medical Cardiac Rhythm Management Division |
| Distribution | US |
Product
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
Reason
An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.
Identifiers
| code_info | Serial Numbers: 1004962 1004963 1004964 1004965 1004966 1004967 1004968 1004969 1004970 1004971 1004972 100…Serial Numbers: 1004962 1004963 1004964 1004965 1004966 1004967 1004968 1004969 1004970 1004971 1004972 1004973 1004974 1004975 1004976 1004977 1004978 1004979 1004980 1004981 1004982 1004983 1004984 1004985 1004986 1004987 1004988 1004989 1004990 1004991 1004992 1004993 1004994 1004995 1004996 1004997 1004998 1004999 1005000 1005001 1005002 1005003 1005004 1005005 1005006 1005007 1005008 1005009 1005010 1005011 1005139 1005140 1005141 1005142 1005143 1005144 1005145 1005146 1005147 1005148 1005149 1005150 1005151 1005152 1005153 1005154 1005155 1005156 1005157 1005158 1005159 1005160 1005161 1005162 1005163 1005164 1005165 1005166 1005167 1005168 1005169 1005170 1005171 1005172 1005173 1005174 1005175 1005176 1005177 1005178 1005179 1005180 1005181 1005182 1005183 1005184 1005185 1005186 1005187 1005188 1005311 1005312 1005313 1005314 1005315 1005316 1005317 1005318 1005319 10 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2572-2014%22
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