FDA MedWatch - HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Loose Connectors May Prevent Alarm from Sounding

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HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Loose Connectors May Prevent Alarm from Sounding

AUDIENCE: Risk Manager, Nursing

ISSUE: HeartWare Inc. is recalling 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.

• Serial Numbers: HW001 to HW11270, and HW20001 to HW 20296
• Product Codes: 1100, 1101, 1102, 1103, 1104, 1205
• Manufacturing Dates: March 6, 2006 to October 17, 2016

BACKGROUND: The 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. The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump. The HVAD is designed for use both in and out of hospital settings, including during patient transport.

RECOMMENDATION: On June 8, 2016, HeartWare Inc. sent an "Urgent Medical Device Correction" letter to affected customers. The letter instructed providers who care for these patients to:

• Remind patients about the safe use of the HVAD System, particularly with regard to moisture and proper connection to power and data sources.
• Inspect controllers for loose connectors by gently pressing on each connector and feeling for atypical movement.
• If a loose connector is identified, replace with a controller from inventory and contact your local HeartWare representative
• If the loose controller is the patient's primary controller, perform a careful benefit risk analysis before using the device.
• Sign and return the "Acknowledgement Form" to HeartWare Quality Compliance via email at FSCA@heartware.com, or fax it to (305) 364-2665 within 30 days.

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 Recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm527148.htm

Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration