The Recall Desk

Manufacturer

Medtronic CoreValve LLC

2 recalls in our database name Medtronic CoreValve LLC as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2020-03-18

Of the 2 recalls from Medtronic CoreValve LLC 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 listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1450-2020·2020-03-18

    Medtronic Simulus 850 Sizer Kits Recalled Due to Porcine Tissue Contact

    Medtronic is recalling six Simulus 850 Semi Rigid Ring/Band Accessory Kits because demonstration units may have contacted porcine tissue.

    Product
    Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2020·2020-03-18

    Medtronic Simulus 750 Flexible Ring/Band Accessory Kit Recalled for Tissue Contact

    Medtronic CoreValve LLC is recalling six Simulus 750 Flexible Ring/Band Accessory Kits because demonstration units may have contacted non-human tissue.

    Product
    Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide