FDA MedWatch - Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software

AUDIENCE: Cardiology, Risk Manager, Transplantation, Nursing, Patient

ISSUE: Medtronic Mechanical Circulatory Support is expanding this recall to include an additional product code and instructions to exchange recalled products.

The company recalled the HVAD controller due to a loose power connector which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death.

Since the issuance of the November 2016 recall, Medtronic Mechanical Circulatory Support has developed an updated HVAD controller and power management software to address the power connector issues.

• Serial Numbers: All HeartWare Controllers
• Product Codes: 1400, 1401, 1403, 1407, and the additional code 1435 for the HVAD DC adapter
• Manufacturing Dates: March 1, 2006 to December 1, 2016
• Distribution Dates: October 11, 2006 to December 1, 2016

BACKGROUND: The HeartWare Ventricular Assist Device (HVAD) helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant.

RECOMMENDATIONS:

• Review the notice and forms, and forward the notice to other staff within their organizations for their awareness;
• Complete, sign, and return the “Acknowledgement Form” to Medtronic Mechanical Circulatory Support within 30 days of receipt of the letter;
• Complete training that will cover the new product labeling including the instructions for use and patient manual;
• Quarantine and replace affected HVAD controllers, DC adapters, instructions for use, emergency responder guides and patient manuals in hospital inventory after training is complete;
• Notify and schedule each of their patients as soon as possible for an appointment to exchange their controllers;
• Return all quarantined HVAD controllers and DC adapters to Medtronic Mechanical Circulatory Support; and
• Once the affected product in inventory has been identified and returned, complete and return the “Completion Form” to con2.0@xxxxxxxxxxxxx or the Medtronic Mechanical Circulatory Support representative no later than 12 months from the date of the letter according to the instructions on the form.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm556762.htm

---

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)