The Recall Desk
Severity pendingFDA (Devices)·Z-1162-2026·Announced 2026-02-11

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M0

Pending LLM rewrite. Source: FDA_DEVICE Z-1162-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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 recalled product

Product
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Devices

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): M00553530
  • UDI-DI: 8714729904557
  • Lot Numbers: 35985705
  • 35986358
  • 36147098
  • 36147222
  • 36165642
  • 36176423
  • 36190575
  • 36191222
  • 36194448
  • 36218745
  • 36227778
  • 36227779
  • 36241500
  • 36271259
  • 36280398
  • 36293880
  • 36300839
  • 36301620

Distribution

Distributed nationwide across the United States.

Related recalls

Same category