The Recall Desk

Manufacturer

Medtronic Cardiovascular Surgery-the Heart Valve Division

4 recalls in our database name Medtronic Cardiovascular Surgery-the Heart Valve Division as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
1
Most recent
2016-08-24

Of the 4 recalls from Medtronic Cardiovascular Surgery-the Heart Valve Division we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (25%) 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.

1–4 of 4

  • HighFDA (Devices)·Z-2546-2016·2016-08-24

    Medtronic EnVeo Delivery Catheter System Recalled for Vascular Trauma Risk

    Medtronic is recalling 7,319 EnVeo Delivery Catheter Systems worldwide due to a potential for vascular trauma during use.

    Product
    Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2264-2015·2015-08-12

    Medtronic Recalls EnVeo R Loading Systems Due to Particulate Presence

    Medtronic is recalling EnVeo R Loading Systems because of the presence of particulate. The recall affects 6,912 units worldwide, including 540 in the US.

    Product
    EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2623-2014·2014-09-17

    Medtronic Recalls Hancock Apical Left Ventricle Connectors Due to Production Discontinuation

    Medtronic is recalling two units of the Hancock Apical Left Ventricle Connector because the company has decided to discontinue production and distribution of this low-volume product.

    Product
    Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0908-2014·2014-02-12

    Medtronic Mosaic Aortic Obturator Recalled for High Transvalvular Gradients

    Medtronic is recalling Mosaic Aortic Obturators used with Mosaic Porcine Aortic Bioprostheses due to higher-than-expected transvalvular gradients after implant.

    Product
    Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
    Category
    Medical Device
    Distribution
    Distributed nationwide