LATITUDE® Clarity 7260Recalls & reported problems
Boston Scientific Corporation · Device Services Software · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Aug 6, 2026Class IIOpen, Classified
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.
Z-3081-2026 · Root cause: Software design · Recall details · FDA record ↗
Other Recorder, event, implantable cardiac, (with arrhythmia detection) devices
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- LUX-Dx II+™ 60M312-100Boston Scientific Corporation · Recorder, event, implantable cardiac, (with arrhythmia detection)1 recall429 reports
- LUX-Dx™ Insertable Cardiac Monitor M301Boston Scientific Corporation · Recorder, event, implantable cardiac, (with arrhythmia detection)478 reports
- BioMonitor IIIm 450218BIOTRONIK SE & Co. KG · Recorder, event, implantable cardiac, (with arrhythmia detection)373 reports
- BioMonitor 2-AF 398493BIOTRONIK SE & Co. KG · RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)151 reports
- LUX-Dx II™ 60M302-100Boston Scientific Corporation · Recorder, event, implantable cardiac, (with arrhythmia detection)1 recall77 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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