FDA MedWatch - HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop

HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop

AUDIENCE: Risk Manager, Nursing, Critical Care Medicine

ISSUE: The alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their VAS. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death. The company has reported 33 reports of malfunction and one serious injury related to this problem.

• Product Codes: 1101, 1103
• Serial Numbers: All Heartware systems currently in use
• Manufacturing and Distribution Dates: January 2008 to March 2015
• Devices recalled in the US: 1763

BACKGROUND: The HeartWare VAS 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.

HeartWare will replace all defective controllers by the end of June 2016.

RECOMMENDATIONS: HeartWare sent their customers an Urgent Medical Device Correction notice on May 25, 2015 to alert them of the problem and actions to take.

Forward HeartWare’s voluntary safety notice to those individuals within your organization who need to be aware of its content.

1. Identify the patients currently supported by the HVAD System.
2. Distribute the patient communication to those patients directly by FedEx or other traceable communication method. Contact your HeartWare representative for any assistance with this process.
3. Make appointments to see the patients subject to this recall as soon as possible, and inspect their device’s power supply connector ports for wear, twisting, or bending. Consider replacing the controller if necessary.
4. Continue to reinforce the messages described in HeartWare’s voluntary safety notice with your patients during their regularly scheduled appointments.

Patients with questions about this recall should contact their health care provider or the VAD (Ventricular Assist Devices) Coordinator at their hospital center. Health care providers who have questions should contact their HeartWare representative or contact HeartWare’s 24-hour Clinical Support at 1-888-494-6365, or emailFSCA@heartware.com.

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 Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm451456.htm