FDA Device recall Z-0319-2021
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
- FDA Device
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application by Boston Scientific, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0319-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-22 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | AR, FL, IL, TX |
Product
Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
Reason
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.
Identifiers
| code_info | Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 01…Model 3892 v1.04 is installed on Model 3300 LATITUDE Programming Systems with the following serial numbers: 009494 012689 010356 008206 008124 007983 004813 010751 |
|---|
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-0319-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.