FDA Device Recall Z-1161-2026

Boston Scientific Corporation · Marlborough, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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

Lot / serial / GTIN: 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, 36548850, 36548851, 36552680, 36559035, 36559036, 36567446, 36567447, 36567448, 36574150, 36581585, 36581586, 36582790, 36582791, 36585188, 36585189, 36591087, 36592499, 36592660, 36596040, 36596041, 36609818, 36609819, 36610400, 36610401, 36621583, 36621584, 36634546, 36634547, 36664793, 36673195, 36673557, 36673558, 36675688, 36675689, 36675690, 36675692, 36677844, 36677845, 36677846, 36680231, 36680232, 36683260, 36683261, 36683262, 36693971, 36693972, 36717713, 36717714, 36717715, 36717819, 36721863, 36731805, 36731806, 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, 37457217, 37457269, 37459571, 37463623, 37463624, 37463625, 37463628, 37469756, 37469757, 37469758, 37470669, 37472148, 37475121, 37475122, 37481983, 37486079, 37518915, 37518916, 37518917, 37519094, 37532420, 37532421, 37533309, 37543372, 37558499, 37558542, 37567252, 37567253, 37567400, 37568848, 37568849, 37571930, 37685005, 37686597, 37689957, 37689958, 37698144, 37704842, 37761033, 37761034, 37775246, 37776579, 37776720, 37776721, 37780826, 37785688, 37785689, 37811064, 37817121, 37823587, 37823588, 37826529, 37826530, 37827570, 37834839, 37836866, 37836867, 37842827;

Quantity: 266 units

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.

Recall record

Recall number: Z-1161-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: 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.
Recall initiated: 2025-12-19
Classified by FDA Center: 2026-02-05
FDA published: 2026-02-11
Recalling firm: Boston Scientific Corporation
Firm location: Marlborough, MA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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