Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

HeartWare Battery Recalled by Medtronic Inc Due to Batteries for the HVAD system have a weld...

Date: May 5, 2022
Company: Medtronic Inc
Status: Ongoing
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 Medtronic Inc directly.

Affected Products

HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.

Quantity: 429 batteries

Why Was This Recalled?

Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Inc

Medtronic Inc has 17 total recalls tracked by RecallDetector.

Related Recalls

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