Recall Z-0319-2021— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-09-22, terminated 2024-09-04. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-22
- Terminated
- 2024-09-04
- Firm location
- Saint Paul, MN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.