RESONATE EL ICD VR — Class II medical device recall Z-0077-2018
Terminated recall by Boston Scientific Corporation, reported 2017-11-15, distributed in MN, OH. The devices have an incorrect firmware configuration.
| Recall number | Z-0077-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2017-10-04 |
| Classified | 2017-11-08 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2019-10-15 |
| Distributed | MN, OH |
| Quantity | 5 devices |
| Reason classes | software |
| Serial numbers | 224020, 224209, 224322, 224366, 224506 |
| Model numbers | D432 |
Product
RESONATE EL ICD VR, Model D432, Sterile.
Reason for recall
The devices have an incorrect firmware configuration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0077-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.