Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Recalled by Heartware Inc Due to HeartWare, Inc. of Miami Lakes, FL is recalling...

Date: December 27, 2012
Company: Heartware Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Heartware Inc directly.

Affected Products

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

Quantity: 3,544

Why Was This Recalled?

HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Heartware Inc

Heartware Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report