The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1159-2026·Announced 2026-02-11

AXIOS 6mm stents recalled over deployment and expansion problems

Boston Scientific is recalling 39 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 AXIOS Stent and Electrocautery-Enhanced Delivery System, 6mm x 8mm, material number (UPN) M00553680, 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 39 units under UDI-DI 191506008086, 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
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Stent
Hazard
Affected units
39

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): M00553680
  • UDI-DI: 191506008086
  • Lot Numbers: 35950784
  • 35960771
  • 35960772
  • 36156260
  • 36156261
  • 36165653
  • 36167912
  • 36241714
  • 36401105
  • 36408034
  • 36421237
  • 36447549
  • 36447550
  • 36520894
  • 36530482
  • 36530483
  • 36530484
  • 36533326

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 →

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