*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN...
FDA Device Recall #Z-1163-2026 - Class I, December 19, 2025
Recall Summary
| Recall Number | Z-1163-2026 |
| Classification | Class I - Serious risk |
| Date Initiated | December 19, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific Corporation |
| Location | Marlborough, MA |
| Product Type | Devices |
| Quantity | 588 units |
Product Description
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
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 Pattern
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.
Lot / Code Information
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, 36147097, 36154534, 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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, 37176657, 37194095, 37204177, 37204178, 37204179, 37204240, 37204241, 37204809, 37204810, 37204811, 37207470, 37207471, 37208948, 37217600, 37217605, 37217607, 37240010, 37240011, 37252330, 37252331, 37252333, 37252334, 37252335, 37257420, 37257421, 37257422, 37257423, 37261686, 37262942, 37262943, 37262949, 37262950, 37263184, 37263185, 37263554, 37263555, 37268080, 37268081, 37268098, 37269066, 37269067, 37269068, 37272106, 37272107, 37272903, 37272904, 37273840, 37273841, 37274479, 37274863, 37275620, 37276239, 37276361, 37276363, 37276364, 37308911, 37323226, 37323227, 37323228, 37323229, 37324379, 37325180, 37325181, 37325182, 37325354, 37331113, 37379513, 37380940, 37380941, 37380942, 37382298, 37382299, 37384504, 37384505, 37386277, 37386278, 37443960, 37443961, 37443962, 37451306, 37451307, 37456598, 37457260, 37460647, 37460648, 37461035, 37461036, 37463128, 37463129, 37501715, 37501716, 37501717, 37510239, 37511240, 37514184, 37514185, 37514972, 37524755, 37524756, 37524758, 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;
Other Recalls from Boston Scientific Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2962-2026 | Class II | Suture Cinch Long 1pk. Endoscopic tissue app... | Jul 14, 2026 |
| Z-2961-2026 | Class II | OverStitch Suture Cinch, 1pk. Endoscopic tissue... | Jul 14, 2026 |
| Z-2977-2026 | Class I | Boston Scientific ENROUTE Transcarotid Neuropro... | Jul 9, 2026 |
| Z-2978-2026 | Class I | Boston Scientific ENROUTE Transcarotid Neuropro... | Jul 9, 2026 |
| Z-2838-2026 | Class II | Radial Jaw 4 Standard Capacity Biopsy Forceps w... | Jun 30, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.