Model 3300 LATITUDE Programming System with installed Model 3892… — Class II medical device recall Z-0319-2021
Terminated recall by Boston Scientific Corporation, reported 2020-11-11, distributed in AR, FL, IL, TX. There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that
| Recall number | Z-0319-2021 |
|---|---|
| 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 | 2020-09-22 |
| Classified | 2020-10-31 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2024-09-04 |
| Distributed | AR, FL, IL, TX |
| Quantity | 8 devices |
| Serial numbers | 004813, 007983, 008124, 008206, 009494, 010356, 010751, 012689 |
| Model numbers | 3300, 3892, V1.04 |
Product
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Reason for recall
There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
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-0319-2021. 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.