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.

Medtronic HVAD Battery Recalled by Heartware, Inc. Due to There is the potential for the Controller power...

Date: February 26, 2021
Company: Heartware, 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 Heartware, Inc. directly.

Affected Products

Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE

Quantity: 114,133 devices (66,613 US)

Why Was This Recalled?

There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

Where Was This Sold?

Worldwide

About Heartware, Inc.

Heartware, Inc. has 60 total recalls tracked by RecallDetector.

Related Recalls

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