FDA MedWatch – HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports by Medtronic:

TOPIC: HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports by Medtronic: Class I Recall – Due to Risk of Damage to Controller Ports

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: Medtronic is recalling the HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports because of risk of wear and tear of the connector plugs (power sources, data cable, and alarm adapter) which could cause damage to the Controller port metal pins (for example, bent pins).

Damaged controller ports may prevent power cables and data cables from being connected to the controller and lead to a full or partial stop of the pump. This could cause serious patient harm including loss of consciousness, hospitalization, heart attack, or death.

There have been 855 complaints about this device issue and 8 reports of injuries. Twelve deaths have been reported.

For more information and recommendations about this recall, click on the red button “Read Recall” below.

BACKGROUND: The HeartWare Ventricular Assist Device (HVAD) Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports are part of the HeartWare HVAD System, which is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients where new transplants are not planned.

RECOMMENDATIONS:  On February 26, 2021, Medtronic sent an Urgent Medical Device Notice to all affected customers. The notice instructed customers to:

• Review the content in Appendix A of the Urgent Medical Device Notice that provides additional instructions on the frequency of inspecting the HVADTM Controller, HVADTM Controller power cables (AC Adapter, DC Adapter, and Battery cables), and HVADTM Monitor data cables.
• Review the content in Appendix A of the Urgent Medical Device Notice with your patients who are currently on support.
• Share the notice with all those who need to be aware within organizations or to any organization where potentially affected patients have been transferred.
• Complete a Customer Confirmation Form (enclosed with the Urgent Medical Device Notice) and return.

Health 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.