The Recall Desk

Hazard

Valve Damage recalls

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2026-07-29

Of the 3 valve damage recalls we have scored against our rubric, 0 (0%) 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 valve damage 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.

1–3 of 3

  • HighFDA (Devices)·Z-2757-2026·2026-07-29

    Boston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage

    Boston Scientific is recalling its Faradrive Steerable Sheath devices due to potential hemostatic valve damage during preparation, which may cause air ingress and patient harm.

    Product
    FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2026·2026-07-29

    FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk

    Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.

    Product
    FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2755-2026·2026-07-29

    FARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall

    Boston Scientific recalls FARADRIVE STEERABLE SHEATH CLEAR due to valve damage risk that could cause air embolism during heart procedures.

    Product
    FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
    Category
    Medical Device
    Distribution
    Distributed nationwide