The Recall Desk

Hazard

Outflow Obstruction recalls

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

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2024-03-27

Of the 1 outflow obstruction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) 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 outflow obstruction 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.

1–1 of 1

  • SevereFDA (Devices)·Z-1300-2024·2024-03-27

    FDA Recalls HeartMate II Left Ventricular Assist Systems for Graft Obstruction

    Thoratec Corp. recalls HeartMate II left ventricular assist system kits due to outflow graft deformation that could obstruct blood flow. The FDA has classified this as a Class I recall affecting 2,240 units distributed worldwide.

    Product
    HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular As
    Category
    Medical Device
    Distribution
    Distributed nationwide