The Recall Desk

Manufacturer

Heartware

3 recalls in our database name Heartware as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2018-06-06

Of the 3 recalls from Heartware 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.

1–3 of 3

  • ModerateFDA (Devices)·Z-1903-2018·2018-06-06

    Heartware Medtronic HVAD System Recalled for Transient Electrical Interruptions

    Heartware is recalling HVAD System components due to possible transient electrical connection interruptions that may cause unexpected beeping or power switching.

    Product
    Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2017·2017-05-03

    Heartware Recalls HVAD System Controllers for Exchange

    Heartware is recalling all HVAD System Controllers currently on the market to exchange them for the next generation HVAD Controller (Controller 2.0).

    Product
    HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS)
    Category
    Medical Device
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-1832-2017·2017-05-03

    HeartWare HVAD Pump Driveline Splice Kit Recall for Improved Repair

    Medtronic is notifying clinicians that an improved splice kit is available to replace the HeartWare HVAD Pump Driveline Splice Kit due to a safety issue.

    Product
    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit si
    Category
    Medical Device
    Distribution
    Distributed nationwide