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LUX-Dx II+ recallZ-2048-2026 · Boston Scientific Corporation · initiated Mar 30, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

An IMPORTANT Medical Device Correction notification letter dated 3/30/26 was sent to customers. Recommendations As noted previously, Boston Scientific released an update to LATITUDE Clarity on March 27, 2026 to correct this programming discrepancy. Devices impacted by this issue will be automatically corrected to the clinician assigned programming once the device successfully reconnects with LATITUDE Clarity. To confirm updated programming settings have been applied to the impacted M302/M312 device: " Navigate to the patient s profile on LATITUDE Clarity; " Verify that the last connection to the device occurred after March 27, 2026. If not, the patient will need to reconnect their mobile monitor; " Check device programming under Counters and Settings and verify that Brady, Pause, and PVC Burden are set as desired; " Complete and return the enclosed Acknowledgment Form per the instructions. Boston Scientific s RhythmCARE" Support Team is available to assist HCPs with resolving this programming discrepancy, confirming programmed settings, or assisting with reconnecting a patient, either remotely or in-clinic. Additional Information Patient safety remains Boston Scientific s highest priority. We recognize the impact of this device behavior on both you and your patients, and we are committed to transparent communication with physicians and other HCPs to ensure you have relevant information for managing your patients. If you have additional questions regarding the information described above or would like to report a clinical event, please contact the Boston Scientific RhythmCARE Support team. Adverse events may also be reported directly to the FDA s MedWatch Adverse Event Reporting program. United States RhythmCARE Support 1.800.CARDIAC (227.3422) [email protected]

Recall details

Recall number
Z-2048-2026
Status
Open, Classified
Initiated by the company
Mar 30, 2026
Posted by the FDA
May 1, 2026
Recalling firm
Boston Scientific Corporation
Quantity
2 units
Product code
MXD
FDA submissions
K231328
Distribution
Worldwide distribution - US Nationwide and the country of Belgium.

Product description

LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

Code information (models, lots, serial numbers)

LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98679).

Sources and updates

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