Class I U.S. Food and Drug Administration

Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System recall: Increased reports of stent deployment and expansion issues. The most common

Recall published 9 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1158-2026
Published
February 11, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Boston Scientific Corporation
Product type
Medical devices
Units affected
557 units
Distribution
Nationwide
Made in
United States
Lot / code info
Material Number (UPN): M00553680; UDI-DI: 8714729951179; Lot Numbers: 35961006, , 35961007, , 35962524, , 35967379, , 35968520, 35968521, 35968597, 35968598, 35971077, 35971078, 35971079, 35972100, 35982272, 35982273, 35982274, 35982275, 35982276, 35982277, 35982278, 35982279, 35982420, 35982424, 35982425, 35985313, 35985314, 35993619, 35993720, 35993721, 36109761, 36109763, 36109764, 36109765, 36109766, 36111314, 36111315, 36118993, 36118994, 36122066, 36122067, 36122075, 36132801, 36132802, 36132803, 36132804, 36134972, 36144058, 36144059, 36144120, 36144121, 36174475, 36174476, 36178005, 36187588, 36187589, 36187687, 36187688, 36188887, 36188888, 36188889, 36194446, 36194447, 36197239, 36198580, 36217768, 36217769, 36217770, 36227341, 36227342, 36227343, 36228603, 36228604, 36228605, 36235934, 36236151, 36240589, 36240590, 36241715, 36241716, 36241717, 36251363, 36251364, 36253000, 36253008, 36253041, 36260860, 36260861, 36260862, 36261599, 36261780, 36261781, 36261834, 36261835, 36280395, 36280396, 36280397, 36281912, 36281913, 36281914, 36283860, 36292682, 36292683, 36292684, 36292689, 36292690, 36292691, 36294495, 36301621, 36301622, 36301623, 36301624, 36302290, 36302291, 36302292, 36319024, 36319025, 36319026, 36320016, 36320017, 36323789, 36323790, 36324720, 36325159, 36325560, 36325568, 36325569, 36332101, 36332102, 36341577, 36342114, 36342418, 36352008, 36352009, 36355049, 36355050, 36355752, 36359567, 36362263, 36362264, 36362265, 36363150, , 36363151, , 36364647, , 36372361, , 36372362, 36377757, 36378548, 36380549, 36388531, 36390612, 36396985, 36399492, 36403441, 36408983, 36408984, 36417820, 36417821, 36418721, 36418722, 36424650, 36424651, 36424652, 36425889, 36425890, 36425891, 36425892, 36462323, 36462324, 36469427, 36469428, 36469812, 36472250, 36472253, 36472254, 36475370, 36478478, 36478479, 36572740, 36572741, 36573582, 36573583, 36573587, 36573588, 36573589, 36573590, 36591073, 36591074, 36591075, 36603384, 36603385, 36603386, 36604188, 36604189, 36604190, 36604191, 36604748, 36604749, 36607249, 36607250, 36607251, 36607252, 36607253, 36610818, 36610819, 36611060, 36615703, 36615704, 36621589, 36621590, 36623324, 36623325, 36623326, 36693849, 36693850, 36693851, 36693852, 36694699, 36695020, 36695021, 36695023, 36698247, 36698249, 36698251, 36698527, 36698528, 36698529, 36698530, 36698531, 36698532, 36706712, 36706713, 36706714, 36706715, 36709766, 36709767, 36709768, 36709769, 36713255, 36713256, 36713257, 36713258, 36717717, 36717718, 36717719, 36717800, 36717801, 36717802, 36718966, 36718967, 36723909, 36723910, 36728154, 36764237, 36764238, 36767449, 36767450, 36771884, 36771885, 36771886, 36785593, 36788793, 36788794, 36788795, 36795369, 36795370, 36796430, 36796431, 36804013, 36804375, 36839665, 36895362, 36895363, 36895364, 36958216, 36958217, 36962750, 36970218, 36970219, 36980309, 36980310, , 36981855, , 36981856, , 36982694, , 36983909, 36985933, 36988630, 36988631, 36988632, 36990382, 36990383, 36991168, 36991170, 36991683, 36992721, 37014102, 37014103, 37014104, 37027339, 37028180, 37028181, 37030756, 37032104, 37036344, 37036345, 37037505, 37037506, 37040169, 37041012, 37041435, 37041436, 37046449, 37046450, 37046928, 37046929, 37048665, 37049464, 37049465, 37049874, 37050321, 37050322, 37050323, 37055465, 37055466, 37055467, 37056013, 37056014, 37057032, 37059006, 37059010, 37094844, 37106164, 37106583, 37131143, 37131144, 37131145, 37131146, 37177253, 37177271, 37177272, 37179955, 37179956, 37180902, 37180903, 37182323, 37183490, 37188257, 37188258, 37197563, 37197578, 37198908, 37199019, 37199360, 37199361, 37199972, 37199973, 37209169, 37209170, 37209171, 37211282, 37211285, 37212243, 37212244, 37212245, 37212246, 37213246, 37213247, 37213248, 37213249, 37240012, 37240013, 37240236, 37240237, 37240249, 37240250, 37240252, 37240254, 37242247, 37242248, 37242249, 37243754, 37243755, 37243756, 37247304, 37247305, 37247306, 37283604, 37283605, 37291851, 37291852, 37292951, 37292952, 37296…
UPC codes
8714729951179

Products covered by this recall

AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 8714729951179

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 35961006
  • 35961007
  • 35962524
  • 35967379
  • 35968520
  • 35968521
  • 359

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Boston Scientific Corporation — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Boston Scientific Corporation — 100 Boston Scientific Way, Marlborough, MA, 01752-1234

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Boston Scientific Corporation medical devices recalled?

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. Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 8714729951179; lot code 35961006, 35961007, 35962524. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls