DeviceSignal · Recall classified
Boston Scientific Corporation
FDA classified a device recall on 2026-09-02 · Class II · Z-3081-2026
EventRecall classified
Effective2026-09-02
ClassificationClass II
On 2026-09-02 the FDA classified a device recall from Boston Scientific Corporation as Class II. Product: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…. Recall Z-3081-2026. The firm initiated it on 2026-08-06. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3081-2026
- Classification
- Class II
- Classified on
- 2026-09-02
- Initiated on
- 2026-08-06
- Firm
- Boston Scientific Corporation
- Reason
- There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
- Product
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3081-2026- Snapshot hash
2ad9ab6cbee6c5eb2f0d4298731a8c9755893d917528d78bf00a015fa69a0494- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
e0abac2f1cd8384a84b52144031454f95e1e0cecc4259fb6f5b9f58802caa0bb- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)