*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Summary
The FDA issued a Class I for *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Mat by Boston Scientific Corporation. Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the ste.
Details
Source
Device Recall
External ID
Z-1163-2026
Action Date
2026-02-11
Status
Ongoing
Category
device
Product Description
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Lot/Code Info: 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, 36102812, 36102813, 36102814, 36135590, 36135591, 36144122, 36144123, 36147096, 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36551004, 36559039, 36559580, 36559581, 36559582, 36559583, 36560842, 36560843, 36562844, 36562845, 36565931, 36566528, 36567449, 36570785, 36570786, 36570787, 36572359, 36581587, 36583578, 36583579, 36591069, 36591070, 36591071, 36591072, 36612260, 36612261, 36616444, 36616445, 36619789, 36619790, 36619791, 36619792, 36619793, 36621321, 36621322, 36621323, 36625032, 36625033, 36625034, 36625035, 36626350, 36626351, 36626352, 36633245, 36633246, 36640831, 36641049, 36641909, 36641910, 36642073, 36642074, 36642075, 36642562, 36643731, 36643732, 36645532, 36645533, 36645534, 36647015, 36662774, 36662775, 36662776, 36662778, 36662779, 36664061, 36664062, 36664063, 36664064, 36664065, 36664567, 36664568, 36664794, 36664796, 36665694, 36665695, 36669412, 36669413, 36669414, 36669415, 36669416, 36669417, 36669418, 36674810, 36674811, 36674812, 36674813, 36677847, 36683263, 36684615, 36685905, 36685906, 36804376, 36814735, 36816919, 36818381, 36818382, 36821877, 36823193, 36823194, 36828324, 36828325, 36829194, 36829196, 36835382, 36835383, 36838544, 36838545, 36838546, 36838547, 36839663, 36839664, 36847979, 36848665, 36848666, 36851793, 36851794, 36853105, 36853106, 36853594, 36853595, 36854299, 36856185, 36856186, 36856187, 36856188, 36856340, 36856341, 36856342, 36866851, 36866852, 36866853, 36868980, 36868981, 36868982, 36868983, 36868984, 36869884, 36869885, 36869886, 36869887, 36869888, 36869889, 36869890, 36869891, 36875736, 36875737, 36877081, 36877082, 36877084, 36877085, 36880763, 36880764, 36897772, 36897773, 36959806, 36959807, 36994050, 36994051, 36994052, 36995011, 36995012, 36999167, 36999494, 37004725, 37004726, 37004727, 37059011, 37060652, 37067633, 37069356, 37069357, 37075264, 37075265, 37078233, 37078234, 37093209, 37093210, 37093302, 37093303, 37096513, 37096514, 37099739, 37132500, 37132501, 37132502, 37134087, 37137422, 37137423, 37140068, 37152588, 37153325, 37157514, 37161889, 37161890, 37164067, 37164068, 37167102, 37167103, 37167775, 37176653, 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37530261, 37536574, 37538606, 37541652, 37543964, 37543965, 37543966, 37544646, 37544647, 37544648, 37548357, 37548358, 37549491, 37549492, 37552245, 37552246, 37552247, 37552248, 37554898, 37567401, 37567402, 37567403, 37567404, 37567405, 37567406, 37601264, 37601265, 37601266, 37611305, 37611306, 37611307, 37611308, 37617701, 37617702, 37625483, 37625484, 37644410, 37649490, 37651467, 37655139, 37655280, 37655281, 37660774, 37660775, 37660777, 37660778, 37665497, 37667998, 37672121, 37675664, 37675665, 37689944, 37689945, 37696688, 37720785, 37723579, 37731195, 37731196, 37731197, 37742018, 37745174, 37746915, 37750340, 37750341, 37754384, 37754385, 37755928, 37755939, 37771352, 37771353, 37771354, 37771355, 37777208, 37778063, 37780175, 37780176, 37809876, 37809877, 37809878, 37809879, 37811060, 37811061, 37811062, 37811063, 37817124, 37817482, 37817483, 37820575, 37820576, 37820577, 37837386, 37837890, 37837891, 37844022, 37846410, 37846411, 37846412;
Quantity Affected: 588 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-19
Company
Marlborough, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 207 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1163-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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