Use caution Medical device recall · FDA · Published December 20, 2024

Boston Scientific AXIOS Stent Recall: Sheath Tip Detachment Risk

Boston Scientific recalls AXIOS Stent and Delivery System 10mmx10mm UPN M00553740 due to reported sheath tip detachment causing procedure delays. Affected units have specific lot numbers and GTIN.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1030-2025Medical device Boston Scientific ›

Use caution until it’s fixed

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Take action

Contact the company

Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling its AXIOS Stent and Delivery System 10mmx10mm model (UPN: M00553740) because a sheath tip can detach during use, preventing proper stent expansion and requiring extended procedures. This risk affects medical procedures where the stent must expand correctly. Read more at govinfonow.com/recall/53179-boston-scientific-axios-stent-recall-sheath-tip-detachment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53179-boston-scientific-axios-stent-recall-sheath-tip-detachment-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1030-2025

Cite this page

“Boston Scientific AXIOS Stent Recall: Sheath Tip Detachment Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53179-boston-scientific-axios-stent-recall-sheath-tip-detachment-risk. Based on FDA recall #Z-1030-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1030-2025%22&limit=1).

The FDA announced on Dec. 20, 2024, that Boston Scientific Corporation is voluntarily recalling the AXIOS Stent and Delivery System due to a hazard involving the outer sheath tip. The agency issued recall number Z-1030-2025 for the Class II device.

How to tell if you have it

AXIOS Stent and Delivery System 10mmx10mm
UPN: M00553740
UPC: 08714729904625
Lot Numbers: 34477280

The hazard

The FDA states that the outer sheath distal black tip may detach from the device and remain around the stent saddle. This can prevent proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the Aug. 24, 2026, Imager II Angiographic Catheters Recall for tip fracture risk and the Aug. 6, 2026, LUX-Dx Cardiac Monitor System Recall for delayed alerts. Other recent recalls of similar products include the June 26, 2026, Transcarotid Kit Sheath Depth Markings Detachment and the Nov. 11, 2025, Olympus A2660 Inner Sheath and Resection Sheath recalls for ceramic tip breakage risk.

How to tell if you have this one

Check for the model number 'AXIOS Stent and Delivery System 10mmx10mm' with UPN M00553740. The lot number is 34477280 and the GTIN is 08714729904625.

Brand
Boston Scientific
Product
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Category
Medical device

FDA recall event · 14 products

All 14 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide including Puerto Rico Foreign: To be provided

Recall number	Product, codes & lots	Quantity
Z-1024-2025	AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640; GTIN: 08714729904588 Lot Numbers: 32891042, 32900457, 32908438, 33215358, 33215359, 33216060, 33216062, 33219660, 33219662, 33219663, 33315967, 33315970, 33324398, 33500190, 33520871, 33520872, 33537659, 33538481, 33538484, 33559005, 33813654, 33813655, 33871244, 33948086, 33996038, 33996039, 34004999, 34116469, 34116470, 34251352, 34251353, 34261614, 34261615, 34261616, 34263376, 34263377, 34277689, 34277690, 34297653, 34297657, 34512952, 34526862	495 units US; 2 units(OUS)
Z-1025-2025	AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650; GTIN: 08714729904595 Lot Numbers: 32891503, 32946481, 32966087, 32976911, 32986912, 32986913, 32986914, 32996152, 33004776, 33004777, 33004779, 33008425, 33527176, 33547873, 33559652, 33562171, 33568700, 33568705, 33568709, 33580106, 33686169, 33686170, 33686171, 33686172, 33996104, 33996109, 34006713, 34052770, 34052771, 34052772, 34052773, 34065575, 34065576, 34065577, 34065578, 34136366, 33008426, 33008427, 33013790, 33013791, 33038652, 33158792, 33161956, 33219664, 33219665, 33223921, 33223922, 33223925, 33233417, 33233418, 33233419, 33233460, 33233461, 33235723, 33487216, 33487218, 33489572, 33527175, 33686173, 33686174, 33765268, 33765269, 33765271, 33765272, 33765273, 33765274, 33766684, 33775698, 33813656, 33813657, 33813658, 33813659, 33825083, 33825084, 33825087, 33825091, 33873459, 33873923, 33881493, 33996102, 34136369, 34136370, 34142870, 34142871, 34144414, 34144416, 34251354, 34261613, 34261617, 34261618, 34261619, 34263374, 34271464, 34271465, 34276937, 34276938, 34277681, 34286615, 34286616, 34286617, 34286618, 34308441	1144 units US; 60 units (OUS)
Z-1026-2025	AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660; GTIN: 08714729951179 Lot Numbers: 32913258, 32914587, 32914588, 32914951, 32919344, 33161778, 33167722, 33167723, 33167724, 33168696, 33168697, 33217106, 33217107, 33223926, 33223927, 33224949, 33233462, 33234152, 33235720, 33235721, 33242497, 33242560, 33324868, 33333642, 33577901, 33577905, 33661063, 33677043, 33677044, 33677045, 33677046, 33677047, 33677048, 33680523, 33697485, 33767880, 33776935, 33776936, 33778737, 33778738, 33785758, 33785759, 33787022, 33787023, 33787024, 33787025, 33796610, 33804642, 34034896, 34034897, 34034898, 34037953, 34037954, 34037955, 34038584, 34038795, 34047362, 34047364, 34047365, 34074520, 34074521, 34093768, 34093769, 34101923, 34101924, 34126523, 34126524, 34128158, 34130337, 34134859, 34135080, 34136360, 33333648, 33470460, 33488331, 33509930, 33509931, 33509936, 33509937, 33510694, 33510695, 33517861, 33517862, 33568702, 33568703, 33571498, 33577559, 33577900, 33827339, 33883094, 33899654, 33902104, 33902106, 33908817, 33908818, 33908819, 33930901, 33931714, 33939630, 33998884, 33998885, 34004996, 34006717, 34027241, 34142867, 34144887, 34161824, 34161826, 34165830, 34165831, 34172977, 34172979, 34262100, 34307464, 34344894, 34356855, 34364514, 34772813	1399 units; 20 units (OUS)
Z-1027-2025	AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670; GTIN: 08714729979333 Lot Numbers: 32901294, 33223930, 33328461, 33413626, 33459702, 33686175, 33686176, 33766912, 33814306, 33825089, 33860266, 33920983, 33920984, 33930917, 34020982, 34020983, 34111459, 34111480, 34111481, 34135618, 34135619, 34136372, 34271635, 34297652, 34316296	309 units
Z-1028-2025	AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680; GTIN: 00191506008086 Lot Numbers: 33457806, 33512838, 34035520	31 units
Z-1029-2025	AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690; GTIN: 00191506008093 Lot Numbers: 33419782, 33477824, 34116467, 33419783, 33511487	47 units
Z-1030-2025	AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740; GTIN: 08714729904625 Lot Numbers: 34477280	12 units
Z-1031-2025	AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750; GTIN: 08714729904632 Lot Numbers: 33740402, 33785754, 34037422	38 units
Z-1032-2025	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520; GTIN: 08714729904540 Lot Numbers: 33336402, 33336404, 33336405, 33336411, 33392916, 33392917, 33393302, 33411607, 33437479, 33548501, 33577903, 33704371, 33712822, 33986537, 34017087, 34017088, 34017089, 34028458, 34065579, 34065660, 34083271, 34083272	263 units (OUS)
Z-1033-2025	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530; GTIN: 08714729904557 Lot Numbers: 33335139, 33335340, 33336413, 33511491, 34015885, 34065661, 34068983, 34101926	91 units (OUS)
Z-1034-2025	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540; GTIN: 08714729904564 Lot Numbers: 33169261, 33169263, 33209127, 33243075, 33243077, 33243856, 33255964, 33488328, 33787031, 33787032, 33853395, 33882221, 33882222, 33899656, 33909280, 33979053, 33979055, 34027245, 34027246, 34035523, 34035524, 34052776, 34052778, 34161831, 34161832, 34161833, 34161834, 34190943, 34190944, 34190945, 34192326, 34192327, 34201917, 34203537, 34203539, 34204795, 34223677, 34223679, 34226399, 34226540, 34243427, 34243428, 34375175, 34381803, 34585408, 34731098	519 units (OUS)
Z-1035-2025	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550; GTIN: 08714729904571 Lot Numbers: 32868212, 32947950, 32998424, 32998425, 33177074, 33177075, 33177077, 33185872, 33185873, 33185874, 33185875, 33185877, 33187647, 33187648, 33195395, 33195397, 33209120, 33209135, 33209138, 33209139, 33209840, 33243859, 33257462, 33257474, 33257477, 33268719, 33278543, 33284513, 33284514, 33284517, 33293229, 33301038, 33301039, 33301341, 33315855, 33315856, 33317299, 33318093, 33527177, 33537640, 33538743, 33577557, 33688060, 33688061, 33747542, 33747543, 33749929, 33749930, 33756082, 33756083, 33765265, 33765266, 33804645, 33805203, 33805205, 33805206, 33805208, 33893271, 33902105, 33933459, 33939639, 33948084, 33986699, 33987798, 33987799, 33988020, 33988021, 33988022, 33988779, 33989320, 34015887, 34028520, 34035525, 34035526, 34035529, 34035530, 34035965, 34044970, 34044971, 34044972, 34044973, 34047717, 34047718, 34047819, 34065662, 34065663, 34065664, 34065665, 34074525, 34074528, 34083208, 34085560, 34085561, 34086663, 34093771, 34095708, 34095710, 34095711, 34116466, 34126531, 34126534, 34126535, 34128862, 34135087, 34135090, 34161836, 34161837, 34161838, 34161839, 34163750, 34163751, 34172106, 34172107, 34180838, 34181501, 34182330, 34190948, 34201919, 34232994, 34232995, 34232997, 34334695, 34334696, 34335369, 34371098, 34372194, 34375171, 34375173, 34381805, 34512950	1530 units (OUS)
Z-1036-2025	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560; GTIN: 08714729951100 Lot Numbers: 32865866, 32874910, 32875944, 32876867, 32876869, 32876870, 33195387, 33195388, 33195389, 33195390, 33209841, 33209843, 33215357, 33283337, 33284518, 33284519, 33288532, 33288534, 33301346, 33301347, 33301348, 33301351, 33301352, 33466658, 33467021, 33470461, 33470464, 33470465, 33486865, 33487939, 33519203, 33528652, 33581298, 33581681, 33601247, 33657824, 33686163, 33686166, 33765267, 33804643, 33806748, 33909812, 33909813, 33920980, 33948082, 33977789, 33981155, 33981156, 34006718, 34015882, 34020432, 34020433, 34020434, 34027240, 34047363, 34065574, 34074522, 34076577, 34083205, 34085563, 34101925, 34102569, 34102570, 34102571, 34103179, 34103340, 34111453, 34111454, 34111456, 34111845, 34116472, 34116473, 34126522, 34180835, 34190940, 34190949, 34201914, 34205933, 34205934, 34213826, 34214585, 34214586, 34223572, 34223574, 34325972, 34325974, 34334692, 34335366, 34371087, 34371088, 34371090, 34523681, 34545213, 34649321, 34815303	1102 units (OUS)
Z-1037-2025	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570; GTIN: 08714729976684 Lot Numbers: 32878539, 33336847, 33338446, 33775901, 33795273, 33900261, 33900262, 34076575, 34083270, 34172108, 34172109	118 units (OUS)

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on the device as 'AXIOS Stent and Delivery System 10mmx10mm' with UPN M00553740.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide including Puerto Rico Foreign: To be provided” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 47 days after the firm started it.

Dec 20, 2024Firm started the recall
Jan 30, 2025FDA classified it Class II
Feb 5, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/53179-boston-scientific-axios-stent-recall-sheath-tip-detachment-risk">Boston Scientific AXIOS Stent Recall: Sheath Tip Detachment Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1030-2025 (December 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1030-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.