EMBLEM S-ICD Pulse Generator Model A209 — Class II medical device recall Z-2441-2023
Ongoing recall by Boston Scientific Corporation, reported 2023-08-30. There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may caus
| Recall number | Z-2441-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2023-07-11 |
| Classified | 2023-08-22 |
| Reported by FDA | 2023-08-30 |
| Quantity | 3,856 units |
| UPC / GTIN / UDI-DI | 00802526544101, 00802526548406, 00802526575105, 00802526575112, 00802526575129, 00802526575136, 00802526575143, 00802526575167, 00802526575181, 00802526575204, 00802526575211, 00802526575228, 00802526599002 |
| Model numbers | A209 |
Product
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Reason for recall
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
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-2441-2023. 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.