FDA recall, , High risk
Boston Scientific AXIOS and HOT AXIOS Stent and Delivery Systems
AXIOS Stent and Electrocautery-Enhanced Delivery Systems may have deployment and expansion issues.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation is recalling certain AXIOS Stent and Electrocautery-Enhanced Delivery Systems due to increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.
The recall affects AXIOS Stent and Electrocautery-Enhanced Delivery Systems in sizes 20mm x 10mm, 6mm x 8mm, and 8mm x 8mm, as well as HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems in sizes 6mm x 8mm, 8mm x 8mm, and 20mm x 10mm. Distribution is worldwide, including US Nationwide and Puerto Rico. The company began the recall on December 19, 2025.
What to do
We don't have product-specific 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?
6 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Hot AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
- UDI-DI
- 8714729904540
- 36067957
- 36067958
- 36067959
- 36067960
- 36067961
- 36099410
- 36102139
- 36111317
- 36111318
- 36111319
- 36132439
- 36132800
- 36136724
- 36136725
- 36144054
- 36154527
- 36154528
- 36154529
- 36156019
- 36164532
- 36164990
- 36176206
- 36176207
- 36177448
- 36191239
- 36199389
- 36199390
- 36217761
- 36241713
- 36251361
- 36252913
- 36271441
- 36271442
- 36281910
- 36281911
- 36292639
- 36292680
- 36292681
- 36293836
- 36300838
- 36317858
- 36317859
- 36318240
- 36323786
- 36323787
- 36331036
- 36331037
- 36331038
- 36331039
- 36397921
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- 36421238
- 36424644
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- 36427248
- 36446498
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- 36458829
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- 36461959
- 36462320
- 36468392
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- 36502795
- 36506161
- 36506163
- 36509326
- 36520053
- 36523274
- 36528114
- 36536932
- 36536933
- 36548030
- 36548031
- 36548850
- 36548851
- 36552680
- 36559035
- 36559036
- 36567446
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- 36574150
- 36581585
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- 36585188
- 36585189
- 36591087
- 36592499
- 36592660
- 36596040
- 36596041
- 36609818
- 36609819
- 36610400
- 36610401
- 36621583
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- 36634546
- 36634547
- 36664793
- 36673195
- 36673557
- 36673558
- 36675688
- 36675689
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- 36675692
- 36677844
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- 36677846
- 36680231
- 36680232
- 36683260
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- 36693971
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- 36717713
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- 36717819
- 36721863
- 36731805
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- 36738965
- 36738966
- 36743835
- 36750922
- 36750924
- 36753179
- 36753400
- 36781577
- 36781578
- 36781579
- 36784378
- 36784379
- 36788332
- 36788333
- 36788334
- 36792650
- 36799316
- 36832750
- 36832837
- 36832838
- 36833682
- 36834573
- 36843542
- 36844231
- 36846161
- 36846163
- 36864951
- 36864952
- 36865501
- 36865502
- 36865504
- 36865553
- 36868065
- 36872344
- 36872346
- 36878419
- 36884609
- 36884612
- 36884613
- 36895367
- 36895368
- 36896664
- 36907033
- 36907249
- 36907378
- 36907400
- 36914565
- 36915206
- 36915207
- 36916329
- 36916330
- 36917403
- 36917404
- 36917993
- 37000847
- 37003365
- 37423232
- 37423233
- 37427258
- 37427259
- 37427360
- 37427361
- 37427362
- 37437936
- 37438283
- 37438286
- 37438287
- 37439978
- 37440320
- 37451304
- 37456594
- 37457216
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- 37457269
- 37459571
- 37463623
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- 37463625
- 37463628
- 37469756
- 37469757
- 37469758
- 37470669
- 37472148
- 37475121
- 37475122
- 37481983
- 37486079
- 37518915
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- 37519094
- 37532420
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- 37533309
- 37543372
- 37558499
- 37558542
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- 37567400
- 37568848
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- 37571930
- 37685005
- 37686597
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- 37817121
- 37823587
- 37823588
- 37826529
- 37826530
- 37827570
- 37834839
- 37836866
- 37836867
- 37842827
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
- UDI-DI
- 8714729951179
- 35961006
- 35961007
- 35962524
- 35967379
- 35968520
- 35968521
- 35968597
- 35968598
- 35971077
- 35971078
- 35971079
- 35972100
- 35982272
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- 36109761
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- 36111314
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- 36118993
- 36118994
- 36122066
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- 36122075
- 36132801
- 36132802
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- 36134972
- 36144058
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- 36144120
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- 36174475
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- 36178005
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- 36197239
- 36198580
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- 36253000
- 36253008
- 36253041
- 36260860
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- 36280395
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- 36324720
- 36325159
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- 36985933
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- 37820578
- 37823439
- 37826531
- 37826532
- 37832473
- 37832474
- 37833962
- 37833963
- 37834751
- 37844023
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
- UDI-DI
- 191506008086
- 35950784
- 35960771
- 35960772
- 36156260
- 36156261
- 36165653
- 36167912
- 36241714
- 36401105
- 36408034
- 36421237
- 36447549
- 36447550
- 36520894
- 36530482
- 36530483
- 36530484
- 36533326
- 36536257
- 36536258
- 36570788
- 36570789
- 36578110
- 36581584
- 36603297
- 36611362
- 37014108
- 37429734
- 37429735
- 37433804
- 37433805
- 37440329
- 37451303
- 37456593
- 37495326
- 37511241
- 37519092
- 37519093
- 37780825
*Hot AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
- UDI-DI
- 8714729904557
- 35985705
- 35986358
- 36147098
- 36147222
- 36165642
- 36176423
- 36190575
- 36191222
- 36194448
- 36218745
- 36227778
- 36227779
- 36241500
- 36271259
- 36280398
- 36293880
- 36300839
- 36301620
- 36343103
- 36343104
- 36364646
- 36425887
- 36469811
- 36471228
- 36491879
- 36492660
- 36506029
- 36510220
- 36510221
- 36513401
- 36513402
- 36513403
- 36517139
- 36517220
- 36525208
- 36525209
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- 36534514
- 36534518
- 36536259
- 36536480
- 36536481
- 36551000
- 36551001
- 36642564
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- 36645775
- 36663654
- 36677842
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- 36684887
- 36684888
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- 36757493
- 36757494
- 36761827
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- 36845422
- 36846169
- 36846176
- 36851617
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- 36907028
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- 37823589
- 37823590
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*Hot AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
- UDI-DI
- 8714729951100
- 35793920
- 35952745
- 35961004
- 35995006
- 35995007
- 35995165
- 36001950
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AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
- UDI-DI
- 191506008093
- 35960775
- 35960777
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Recall details
- Company began the recall
- Sold in
Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.
- Company
- Boston Scientific CorporationMarlborough, Massachusetts
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98237
- Recall numbers
- Z-1158-2026 to Z-1163-2026
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
