The Recall Desk

Hazard

Aortic Injury recalls

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

What the numbers show

Total
2
Critical
2
Severe
0
Most recent
2023-08-02

Of the 2 aortic injury recalls we have scored against our rubric, 2 (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 aortic injury 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.

1–2 of 2

  • CriticalFDA (Devices)·Z-2224-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Set fracture causes vascular injury

    Datascope Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.

    Product
    REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2216-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator Fracture During Insertion

    The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.

    Product
    YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIE
    Category
    Medical Device
    Distribution
    Distributed nationwide