FDA Device recall Z-0078-2018
RESONATE EL ICD DR, Model D433, Sterile
- FDA Device
- Class II
- terminated
- Published 2017-11-15
On 2017-11-15 the FDA classified a Class II recall of RESONATE EL ICD DR, Model D433, Sterile by Boston Scientific, citing the devices have an incorrect firmware configuration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0078-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-04 |
| Published | 2017-11-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | MN, OH |
Product
RESONATE EL ICD DR, Model D433, Sterile.
Reason
The devices have an incorrect firmware configuration.
Identifiers
| code_info | Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0078-2018%22
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