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FDA · Medical devicesClass I

Boston Scientific Corporation medical device recall: AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
98237
Recall initiated
Dec 19, 2025
Classified by FDA
Feb 5, 2026
Posted in Enforcement Report
Feb 11, 2026
Recalling firm
Boston Scientific Corporation
Firm location
Marlborough, MA, United States
Initiated by
Voluntary: Firm initiated
Products in this event
6

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

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 most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Dec 19, 2025. FDA classified it 48 days later, on Feb 5, 2026. This recall event covers 6 separate products, each with its own FDA recall number. Distribution reported by FDA: 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,… Boston Scientific Corporation has 169 recalls in our records.

Recalled products (6)

  • Z-1158-2026 Class I Ongoing

    AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;

    Codes / lots: Material Number (UPN): M00553680; UDI-DI: 8714729951179; Lot Numbers: 35961006, , 35961007, , 35962524, , 35967379, , 35968520, 35968521, 35968597, 35968598, 35971077, 35971078, 35971079, 35972100, 35982272, 35982273, 35982274, 35982275, 35982276, 35982277, 35982278, 35982279, 35982420, 35982424, 35982425, 35985313, 35985314, 35993619, 35993720, 35993721, 36109761, 36109763, 36109764, 36109765, 36109766, 36111314, 36111315, 36118993, 36118994, 36122066, 36122067, 36122075, 36132801, 36132802, 36132803, 36132804, 36134972, 36144058, 36144059, 36144120, 36144121, 36174475, 36174476, 36178005, 36187588, 36187589, 36187687, 36187688, 36188887, 36188888, 36188889, 36194446, 36194447, 36197239, 36198580, 36217768, 36217769, 36217770, 36227341, 36227342, 36227343, 36228603, 36228604, 36228605, 36235934, 36236151, 36240589, 36240590, 36241715, 36241716, 36241717, 36251363, 36251364, 36253000,…

    Quantity: 557 units

  • Z-1159-2026 Class I Ongoing

    AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

    Codes / lots: Material Number (UPN): M00553680; UDI-DI: 191506008086; Lot Numbers: 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;

    Quantity: 39 units

  • Z-1160-2026 Class I Ongoing

    AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

    Codes / lots: Material Number (UPN): M00553690; UDI-DI: 191506008093; Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316, 36154532, 36154533, 36241501, 36251362, 36253016, 36293839, 36301625, 36303192, 36420219, 36425888, 36449561, 36458830, 36461449, 36478580, 36492661, 36495673, 36573597, 36573598, 36573599, 36574152, 36576474, 36584299, 36604665, 36731807, 36731808, 36737997, 36743059, 36743200, 36904231, 36904232, 36904233, 36906587, 36907000, 36907001, 36907032, 37217612, 37217613, 37217614, 37440330, 37495327, 37511242, 37602825, 37602826, 37689946, 37694053, 37694054, 37764851, 37764852, 37995048, 37995049, 37995050, 38025042, 38025043,

    Quantity: 59 units

  • Z-1161-2026 Class I Ongoing

    HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

    Codes / lots: Material Number (UPN): M00553520; UDI-DI: 8714729904540; Lot Numbers: 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, 36397922, 36397923, 36421238, 36424644, 36424645, 36427248, 36446498, 36447200, 36447201, 36449569, 36449570, 36449571, 36458829, 36459567, 36459568, 36459569, 36459570, 36461959, 36462320, 36468392, 36468393, 36468394, 36502795, 36506161, 36506163, 36509326, 36520053, 36523274, 36528114, 36536932, 36536933, 36548030, 36548031,…

    Quantity: 266 units

  • Z-1162-2026 Class I Ongoing

    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

    Codes / lots: Material Number (UPN): M00553530; UDI-DI: 8714729904557; Lot Numbers: 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, 36525210, 36534514, 36534518, 36536259, 36536480, 36536481, 36551000, 36551001, 36642564, 36642565, 36642756, 36645775, 36663654, 36677842, 36677843, 36682759, 36684887, 36684888, 36730665, 36730666, 36747824, 36747825, 36753898, 36753899, 36757493, 36757494, 36761827, 36766370, 36766371, 36783265, 36792467, 36792468, 36792469, 36792470, 36792471, 36799315, 36815090, 36815092, 36832774, 36833683, 36836357, 36844783, 36845422, 36846169, 36846176, 36851617, 36851792,…

    Quantity: 150 units

  • Z-1163-2026 Class I Ongoing

    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

    Codes / lots: Material Number (UPN): M00553560; UDI-DI: 8714729951100; Lot Numbers: 35793920, 35952745, 35961004, 35995006, 35995007, 35995165, 36001950, 36001951, 36001952, 36001953, 36002902, 36002903, 36002904, 36003946, 36003947, 36003948, 36012845, 36012846, 36012847, 36012848, 36015761, 36021049, 36021050, 36021051, 36021052, 36027054, 36027055, 36027056, 36027057, 36027058, 36027059, 36027060, 36027061, 36038410, 36038411, 36040000, 36040001, 36040002, 36040003, 36040004, 36048795, 36048796, 36048797, 36048798, 36049282, 36049283, 36049284, 36050387, 36050388, 36050389, 36059222, 36059223, 36059224, 36059225, 36062077, 36062078, 36062079, 36064449, 36065116, 36065117, 36067962, 36067963, 36067964, 36069958, 36069959, 36070600, 36070608, 36070609, 36070610, 36070611, 36072736, 36072737, 36092333, 36092334, 36092335, 36099411, 36099412, 36099413, 36101743, 36101744, 36101745, 36101746, 36101747,…

    Quantity: 588 units

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 98237
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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