Agency classClass IOur severity:Critical FDA (Devices)·Z-1161-2026·Announced 2026-02-11

HOT AXIOS stents recalled over deployment and expansion problems

Boston Scientific is recalling 266 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.

Plain-English summary

The HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 6mm x 8mm, material number (UPN) M00553520, is being recalled by Boston Scientific Corporation.

The reason given in the enforcement record is increased reports of stent deployment and expansion issues. The record states the most common reasonably foreseeable outcome resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one, and that 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.

The record lists 266 units under UDI-DI 8714729904540, with lot numbers recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide including Puerto Rico and a wide range of other countries listed in the record. The FDA has classified the action as Class I, its most serious category.

Facilities should quarantine affected stock and follow Boston Scientific's instructions.

The recalled product

Product: HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Stent
Hazard: deployment-failure
stent-expansion
additional-intervention
class-i
Affected units: 266

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Material Number (UPN): M00553520
UDI-DI: 8714729904540
Lot Numbers: 36067957
36067958
36067959
36067960
36067961
36099410
36102139
36111317
36111318
36111319
36132439
36132800
36136724
36136725
36144054
36154527
36154528
36154529

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Boston Scientific Corporation

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Same hazard · deployment failure