Z-2048-2026Class II

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

Name: Z-2048-2026 LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version...
Creator: Boston Scientific Corporation
Published: 2026-03-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-03-30 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 on 2026-03-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2048-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-30
Posted: 2026-05-01
Recalling firm: Boston Scientific Corporation
Product: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Product code: MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Reason for recall: 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: Under Investigation by firm
Action: 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]
Quantity in commerce: 2 units
Distribution: Worldwide distribution - US Nationwide and the country of Belgium.
Product codes and lots: LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2048-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2048-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-2049-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01

Product code MXD

K231328Class IILUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp / cleared 2023-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)