The Recall Desk

Hazard

Stent Expansion recalls

6 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
6
Critical
6
Severe
0
Most recent
2026-02-11

Of the 6 stent expansion recalls we have scored against our rubric, 6 (100%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all stent expansion recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–6 of 6

  • CriticalFDA (Devices)·Z-1161-2026·2026-02-11

    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.

    Product
    HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1160-2026·2026-02-11

    AXIOS 8mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 59 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System, 8mm x 8mm after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1158-2026·2026-02-11

    AXIOS stents recalled over deployment and expansion problems during placement

    Boston Scientific is recalling 557 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 20mm x 10mm, after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1162-2026·2026-02-11

    HOT AXIOS 8mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 150 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 8mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1163-2026·2026-02-11

    HOT AXIOS 20mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 588 units of the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm after increased reports of stent deployment and expansion issues.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1159-2026·2026-02-11

    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.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
    Category
    Medical Device
    Distribution
    Distributed nationwide