The Recall Desk

Hazard

Cardiac Perforation 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
0
Severe
2
Most recent
2024-02-21

Of the 2 cardiac perforation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (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 cardiac perforation 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

  • SevereFDA (Devices)·Z-0980-2024·2024-02-21

    Impella Cardiac Support Catheters: Risk of Left Ventricle Perforation

    Impella cardiac catheters are being recalled due to risk of left ventricle perforation during operator use. The FDA has classified this Class I recall affecting 91,914 units worldwide.

    Product
    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2880-2020·2020-09-02

    Biosense Webster Recalls CARTO 3 System Software Due to Defect

    Biosense Webster is recalling the CARTO 3 System software due to a defect that may cause tag sites to disappear, potentially leading to cardiac perforation.

    Product
    CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location
    Category
    Medical Device
    Distribution
    Distributed nationwide