FDA recall, , Moderate risk
Boston Scientific LUX-Dx II Arrhythmia Detectors and Alarms
LUX-DX II and LUX-Dx II Plus Arrythmia detectors and alarms may not collect PVC Burden data or monitor for Bradyarrhythmia and Pause.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation, of Saint Paul, Minnesota, initiated a voluntary recall of the LUX-DX II Arrythmia detector and alarm, Model M302, and the LUX-Dx II Plus Arrythmia detector and alarm, Model M312. The recall was added to the FDA's Enforcement Report on May 1, 2026, and distributed nationwide and in Belgium.
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 for both models, and the M312 also is not monitoring for Bradyarrhythmia and Pause. Additionally, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information.
The recall was firm initiated and began on March 30, 2026. The affected products include the LUX-DX II with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5, and the LUX-Dx II Plus with SERVER SW LATITUDE DRAGON EU, Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU, Model 6448, Version 7.5. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI and serial number are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
LUX-DX II, Arrythmia detector and alarm, Model M302, with Server SW Latitude Dragon US, Model 6460, Version 7.5
- UDI-DI
- 00802526620713
- Serial number
- 104263
- 109787
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with Server SW Latitude Dragon EU (Europe), Model 6446, Version 7.5, or Server SW Latitude Dragon AU (Australia/New Zealand), Model 6448, Version 7.5
- UDI-DI
- 00802526620706
- 00802526623707
- 00802526613821
- 00802526613814
- Serial number
- 100085
- 100676
- 100909
- 100944
- 101811
- 102341
- 102405
- 102864
- 102956
- 102978
- 103018
- 105283
- 105697
- 106372
- 106429
- 106690
- 107386
- 107460
- 108132
- 108429
- 108433
- 108641
- 108697
- 108805
- 108861
- 108901
- 109663
- 109699
- 109836
- 110700
- 110737
- 110858
- 111048
- 111119
- 111269
- 111290
- 111362
- 111780
- 111987
- 112265
- 112549
- 113400
- 113495
- 113720
- 114072
- 114393
- 115310
- 115411
- 115835
- 115862
All 148
- 115890
- 115981
- 116066
- 116090
- 116197
- 117180
- 117533
- 117560
- 117820
- 117924
- 117960
- 119462
- 120931
- 121080
- 121203
- 121267
- 121483
- 122855
- 123305
- 123412
- 124378
- 124458
- 124557
- 124791
- 124987
- 125008
- 126249
- 127182
- 127441
- 127758
- 127821
- 128106
- 128506
- 129528
- 129763
- 129782
- 130474
- 131469
- 132487
- 132549
- 133195
- 133786
- 133989
- 134600
- 135362
- 136038
- 136746
- 136884
- 137047
- 137134
- 137319
- 137449
- 138039
- 138059
- 138334
- 138759
- 139080
- 139165
- 140319
- 141181
- 142273
- 143441
- 143887
- 144590
- 144777
- 145284
- 145336
- 145684
- 146709
- 147185
- 147618
- 148972
- 149028
- 153330
- 153628
- 155199
- 155735
- 155898
- 156145
- 156895
- 157872
- 158926
- 159162
- 160236
- 160471
- 160615
- 161307
- 161762
- 162801
- 162821
- 163556
- 163802
- 167866
- 169673
- 169701
- 171284
- 172766
- 175538
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Apr 27, 2026
- Sold in
US Nationwide and the country of Belgium.
- Recalled by
- Boston Scientific CorporationSaint Paul, Minnesota
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 98679
- Recall numbers
- Z-2048-2026 to Z-2049-2026
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Boston Scientific began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
