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 Potential to electrostatic discharged (ESD)

Date: May 16, 2013
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: 76 (US) and 82 (International)

Why Was This Recalled?

Potential to electrostatic discharged (ESD)

Where Was This Sold?

This product was distributed to 29 states: AL, AZ, CA, DE, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NJ, NY, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI, DC

Affected (29 states)Not affected

About HeartWare Inc

HeartWare Inc has 10 total recalls tracked by RecallDetector.

Related Recalls

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