Quick Facts at a Glance
- Recall Date
- March 30, 2026
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific
- Model numbers
- LUX-DX II UDI-DI: 00802526620713, SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US, Serial Number: 104263 109787
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 30, 2026
Reported by FDA DEVICE
May 13, 2026
RecallRadar source check
May 20, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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Full Description
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5. Reason: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.. Classification: Class II. Quantity: 2 units. Distribution: Worldwide distribution - US Nationwide and the country of Belgium.
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Safety Guide
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