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Serious riskFDA DeviceClass I

Boston Scientific HOT AXIOS stent recalled for deployment issues

Boston Scientific's AXIOS Stent (a medical device used in certain procedures) may fail to deploy or expand properly during use. If the stent does not expand as intended, patients may need additional procedures—either endoscopic or surgical—to remove the stent and repair the site.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

  1. If you received this stent, contact your healthcare provider with your lot number immediately
  2. Healthcare providers should check the affected lot numbers listed in the recall notice
  3. Do not use any AXIOS Stent matching the recalled lot numbers
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 6 products — see all of them.

Details

Units affected
588 units
Illnesses reported
None reported
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Classification
Class I
Recall number
Z-1163-2026

In the FDA's words

Description
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560; 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. 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, 36154536, 36154537, 36154538, 36155116, 36155117, 36156264, 36156265, 36164534, 36164535, 36164536, 36165655, 36165656, 36165657, 36165658, 36197586, 36197587, 36197588, 36197589, 36199391, 36200602, 36200603, 36207756, 36207757, 36207758, 36209378, 36209379, 36218689, 36218690, 36218746, 36218747, 36219228, 36271447, 36271448, 36271456, 36271457, 36271458, 36271459, 36271840, 36303991, 36303992, 36303993, 36310699, 36310760, 36310761, 36310762, 36310763, 36310764, 36310765, 36310766, 36310767, 36310768, 36310769, 36447543, 36447544, 36447545, 36447546, 36449567, 36449568, 36458833, 36458834, 36461125, 36478581, 36478582, 36478583, 36478584, 36478585, 36481333, 36481334, 36487762, 36487763, 36487764, 36487765, 36493311, 36493313, 36493314, 36494812, 36494813, 36503314, 36503315, 36503316, 36503317, 36503459, 36504640, 36504702, 36509327, 36517739, 36517821, 36517822, 36519644, 36533327, 36533328, 36548037, 36548038, 36548039, 36548060, 36548061, 36551002, 36551003, 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, 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, 3727
Hazard
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.

6 products in this recall

Boston Scientific AXIOS stent system recalled for deployment risk

Boston Scientific is recalling six versions of its AXIOS Stent and Electrocautery-Enhanced Delivery System after reports that the stent did not deploy or expand properly. The most likely result is a longer procedure while the device is swapped for a new one. In rare cases, the stent may need to be removed through a second endoscopic or surgical procedure. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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