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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Boston Scientific Carotid WALLSTENT Recalled for Delivery System Resistance

Agency Publication Date: August 8, 2025
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Summary

Boston Scientific Corporation is recalling approximately 26,570 units (1,333 in the US and 25,174 internationally) of the Carotid WALLSTENT Monorail Endoprosthesis. This medical device, which includes both the carotid stent and its delivery system, is being removed from the market following reports of physicians encountering unexpected resistance while trying to withdraw the delivery system after the stent was successfully deployed. The recall affects specific material numbers and batches manufactured in the United States and distributed worldwide, including Puerto Rico.

Risk

If the stent delivery system encounters resistance during withdrawal, it may cause a delay in the medical procedure or damage to the blood vessel, such as injury or spasms. In the most severe cases, this issue can lead to a stroke or require additional surgical intervention to correct damage to the stent or vessel.

What You Should Do

  1. This recall affects the Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent and delivery system, sold under various material numbers including H7493915010240, H7493915010310, H749391506220, H749391508210, H749391508290, and several others.
  2. Check the material number and batch code on the product packaging to determine if your inventory is affected. Because there are thousands of affected batches across 19 different product codes, see the Affected Products section below for the full list of affected codes.
  3. Stop using any recalled stent delivery systems immediately.
  4. Contact Boston Scientific Corporation or your medical supply distributor to arrange for the return, replacement, or correction of any unused inventory.
  5. Call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or questions regarding this safety alert.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Carotid WALLSTENT Monorail 10.0-24
Variants: 10.0-24
Model / REF:
H7493915010240
Lot Numbers (52):
35277608
35315983
35315984
35315985
35380314
35452835
35452836
35514614
35551688
35551689
35664523
35664524
35750157
35750158
35750159
35750400
35879409
35879410
35921915
35922951
35926817
35926818
35942366
36056965
36058841
36058842
36058843
36096638
36121883
36138618
36138619
36138801
36138802
36138803
36159671
36195057
36195058
36195059
36195360
36205167
36209423
36214805
36214806
36256192
36322725
36348207
36348208
36348209
36498256
36588496
UDI:
08714729781097
Product: Carotid WALLSTENT Monorail 10.0-31
Variants: 10.0-31
Model / REF:
H7493915010310
Lot Numbers (83):
35294379
35294540
35295922
35330503
35330504
35336132
35347263
35382292
35383351
35383352
35453002
35461487
35461488
35528579
35529200
35628964
35628965
35628966
35641995
35662047
35664484
35664485
35750401
35750402
35750403
35750404
35750405
35750406
35750407
35890012
35893584
35893585
35894358
35894359
35938922
35938923
35938924
35938925
35938926
36002641
36002642
36063291
36063292
36105446
36133161
36134808
36144148
36148535
36154091
36154092
UDI:
08714729781110
Product: Carotid WALLSTENT Monorail 6.0-22
Variants: 6.0-22
Model / REF:
H749391506220
Lot Numbers:
35582211
35750408
35947814
35947815
35950476
36009906
36292862
36397124
36652844
UDI:
08714729781158
Product: Carotid WALLSTENT Monorail 8.0-21
Variants: 8.0-21
Model / REF:
H749391508210
Lot Numbers:
35343574
35438658
35487375
35567637
35652700
35656388
35750409
35757024
35873346
35873347
35901381
35901382
35999854
35999855
35999856
36246587
36246588
36246589
36292863
36306518
36376412
36410418
36410419
36412851
36479267
36565560
36636529
36724350
36777341
UDI:
08714729781172
Product: Carotid WALLSTENT Monorail 8.0-29
Variants: 8.0-29
Model / REF:
H749391508290
Lot Numbers:
35339488
35375416
35375417
35462381
35529285
35529286
35617101
35617102
35618276
35662042
35662043
35749222
35750156
35750410
35750411
35750412
35750413
35771618
35944023
35944024
35946987
35946988
35950477
35950478
35950479
35951080
35951081
35951082
35951083
35961400
35978120
36320917
36320918
36320919
36321560
36322143
36458848
36458849
36458850
36458851
36458852
36465397
36465398
36465399
36505552
36505553
36607622
36683540
36792075
UDI:
08714729781196
Product: Carotid WALLSTENT Monorail 6.0-22 (H965SCH647010)
Variants: 6.0-22
Model / REF:
H965SCH647010
Lot Numbers (70):
35347272
35347273
35347274
35432322
35432323
35432324
35432325
35435587
35496538
35496539
35510448
35510449
35549114
35558691
35558692
35623470
35623471
35623472
35641992
35757022
35891995
35891996
35903878
35903879
35904080
35904081
35911104
35911106
35926007
35926017
35990353
35990354
36009907
36012786
36012787
36012788
36012789
36222681
36222683
36241106
36241107
36241108
36292865
36292866
36292867
36292868
36292869
36292870
36297506
36297507
UDI:
08714729263869
Product: Carotid WALLSTENT Monorail 8.0-21 (H965SCH647070)
Variants: 8.0-21
Model / REF:
H965SCH647070
Lot Numbers (440):
35240183
35240184
35240185
35241830
35241831
35242395
35244198
35302653
35302654
35345323
35345324
35345325
35353957
35353958
35353959
35355526
35355527
35355528
35355529
35355530
35355531
35355532
35355533
35355534
35355535
35388600
35388601
35388602
35388603
35388604
35388605
35390839
35432326
35435588
35435589
35435590
35435591
35435592
35435593
35435594
35435595
35435596
35435597
35435598
35435599
35435640
35435641
35435642
35438652
35438653
UDI:
08714729263876
Product: Carotid WALLSTENT Monorail 8.0-29 (H965SCH647080)
Variants: 8.0-29
Model / REF:
H965SCH647080
Lot Numbers (805):
35243220
35244199
35244520
35244521
35247274
35247275
35247276
35247277
35247278
35247279
35247540
35247541
35248292
35248293
35248294
35252806
35252808
35252809
35302655
35302656
35302657
35302658
35304581
35305305
35305306
35307512
35307513
35307514
35339484
35339485
35339486
35339487
35357498
35357499
35357740
35361258
35361259
35361460
35361461
35361462
35361463
35362807
35362808
35365037
35365038
35365039
35365800
35365801
35365802
35365803
UDI:
08714729263883
Product: Carotid WALLSTENT Monorail 8.0-36 (H965SCH647090)
Variants: 8.0-36
Model / REF:
H965SCH647090
Lot Numbers (170):
35284214
35284216
35284217
35296025
35296026
35296027
35307517
35309535
35309536
35313433
35313434
35313435
35343571
35376080
35376081
35376082
35376083
35395628
35395629
35395630
35406003
35452838
35471394
35471395
35471396
35471397
35471398
35476350
35476351
35476352
35476819
35476960
35514613
35541484
35541485
35541486
35541487
35542644
35542645
35542646
35542647
35588888
35588889
35588890
35594003
35600380
35600381
35600716
35600717
35600718
UDI:
08714729263890
Product: Carotid WALLSTENT Monorail 10.0-24 (H965SCH647120)
Variants: 10.0-24
Model / REF:
H965SCH647120
Lot Numbers (290):
35258269
35258270
35258273
35258274
35260228
35260229
35265522
35265523
35266396
35266397
35266398
35266399
35267871
35267872
35272291
35272292
35273687
35273688
35273689
35274001
35274002
35274003
35274004
35276183
35276184
35276185
35276186
35276187
35277609
35278162
35278163
35278164
35278165
35278167
35281328
35281329
35289305
35306610
35306611
35306612
35310693
35310694
35310695
35310696
35315986
35315987
35315988
35320538
35320539
35324563
UDI:
08714729263906
Product: Carotid WALLSTENT Monorail 10.0-31 (H965SCH647130)
Variants: 10.0-31
Model / REF:
H965SCH647130
Lot Numbers (488):
35258275
35258276
35258277
35258278
35258279
35260230
35260231
35261618
35261619
35264188
35264189
35264190
35264191
35264192
35266488
35266489
35268647
35268648
35278746
35281326
35281327
35285493
35285494
35285495
35285496
35285497
35285498
35285499
35285920
35286196
35286197
35286198
35286199
35286540
35287317
35287319
35287401
35289015
35289303
35293059
35293160
35293161
35293162
35293163
35293812
35293813
35293815
35293816
35320520
35320521
UDI:
08714729263913
Product: Carotid WALLSTENT Monorail 10.0-37 (H965SCH647140)
Variants: 10.0-37
Model / REF:
H965SCH647140
Lot Numbers (109):
35272289
35272290
35278747
35278748
35293817
35293818
35293819
35309703
35309704
35309705
35309706
35320537
35329976
35329978
35329979
35341681
35341682
35344559
35345321
35345329
35347267
35347268
35347269
35383621
35386679
35386780
35386781
35388276
35388277
35428800
35428801
35428802
35428803
35484499
35489527
35489530
35489533
35496534
35496535
35496536
35525178
35530635
35560220
35560221
35560222
35566231
35625591
35625592
35641157
35641460
UDI:
08714729263920
Product: CAROTID WALLSTENT MR 6X22 5F 135CM
Variants: 6X22 5F 135CM
Model / REF:
M001719000
Lot Numbers:
35438655
35438656
35438657
35641993
35641994
36053998
36053999
36223361
36223362
36348206
36523368
36616127
36777256
UDI:
08714729781165
Product: CAROTID WALLSTENT MR 8X21 5F 135CM
Variants: 8X21 5F 135CM
Model / REF:
M001719010
Lot Numbers:
35252807
35307515
35307516
35355536
35450114
35450115
35504179
35504200
35504201
35571041
35583635
35583636
35583637
36223363
36223364
36224129
36224132
36224133
36230818
36297515
36297516
36297518
36297761
36368141
36368142
36412855
36475475
36539307
36616133
36616134
36739202
UDI:
08714729781189
Product: CAROTID WALLSTENT MR 8X29 5F 135CM
Variants: 8X29 5F 135CM
Model / REF:
M001719020
Lot Numbers (66):
35252812
35343568
35343569
35343570
35343572
35355537
35379661
35406002
35476349
35480115
35480116
35542648
35560230
35560231
35629995
35629996
35629997
35636546
35636547
35662002
35662003
35961401
35961402
35961403
35961404
35961405
35970484
35972013
35977619
36006440
36007615
36007616
36007618
36271662
36271663
36271664
36271665
36271666
36275712
36275713
36275714
36275715
36275716
36299150
36299151
36299152
36299153
36299154
36306787
36306788
UDI:
08714729781202
Product: CAROTID WALLSTENT MR 8X36 5F 135CM
Variants: 8X36 5F 135CM
Model / REF:
M001719030
Lot Numbers:
35343573
35347264
35379662
35476961
35476962
35545686
35550309
35550605
35589532
35664483
35749224
35980332
35980333
35997086
36018043
36078429
36087098
36087099
36087540
36096632
36096633
36347227
36397123
36416430
36416431
36563911
36565458
36565459
36635532
36635533
UDI:
08714729781226
Product: CAROTID WALLSTENT MR 10X24 5.9F 135CM
Variants: 10X24 5.9F 135CM
Model / REF:
M001719040
Lot Numbers:
35281323
35281324
35281325
35324570
35324571
35416155
35484495
35547738
35623469
36113886
36113887
36115281
36115282
36124259
36124480
36124481
36169150
36209425
36498340
36711739
36712757
36713869
UDI:
08714729781103
Product: CAROTID WALLSTENT MR 10X31 5.9F 135CM
Variants: 10X31 5.9F 135CM
Model / REF:
M001719050
Lot Numbers:
35293814
35295923
35347265
35347266
35388278
35485560
35553939
35641991
35682792
35939213
35939214
35939215
35939216
36065524
36065525
36065526
36148529
36148532
36508770
36606592
36771557
36817706
UDI:
08714729781127
Product: CAROTID WALLSTENT MR 10X37 5.9F 135CM
Variants: 10X37 5.9F 135CM
Model / REF:
M001719060
Lot Numbers:
35310697
35315981
35315982
35347270
35388279
35496537
35566234
35682793
35978123
36043781
36105452
36159664
36159665
36164840
36498342
UDI:
08714729781141

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97243
Status: Active
Manufacturer: Boston Scientific Corporation
Sold By: Hospital supply distributors; Medical device wholesalers
Manufactured In: United States
Units Affected: 26,570 (1,333 US; 25,174 OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.