FDA Device recall Z-2073-2019
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
- FDA Device
- Class I
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class I recall of ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) by St Jude Medical, citing electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2073-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-06-20 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | St Jude Medical |
| Distribution | US |
Product
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Reason
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Identifiers
| code_info | Serial Number: 1282011, 1282019, 1282065, 1282069, 1282424, 1282458, 1282469, 1282474, 1282596, 1282602, 128…Serial Number: 1282011, 1282019, 1282065, 1282069, 1282424, 1282458, 1282469, 1282474, 1282596, 1282602, 1282609, 1282622, 1282625, 1282638, 1282641, 1282648, 9829389, 9831310, 9831509, 9831515, 9831516 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2073-2019%22
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