FDA MedWatch - HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion

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Title: FDA MedWatch - HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion

HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion

AUDIENCE: Risk Manager, Nursing

ISSUE: HeartWare Inc. is recalling the batteries because they may lose power prematurely due to faulty cells. If the HVAD system is not connected to an additional power source shortly after the system sounds an alarm indicating a low battery level, the pump will stop working and the patient may experience serious adverse health consequences, including death.

This recall includes batteries used on HeartWare Ventricular Assist Device (HVAD), Serial numbers: BAT000001 to BAT199999, Model number 1650, manufacturing dates: May 19, 2013 to July 1, 2015 and distribution dates: May 21, 2013 to July 31, 2015. A total of 18,631 units were recalled nationwide, including Washington D.C.

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.

RECOMMENDATION: On January 7, 2016, HeartWare Inc. sent an "Urgent: Medical Device Recall" letter to affected customers. The letter instructed customers to:

• Complete and return the acknowledgement form attached with the letter
• Identify and quarantine affected batteries under patients’ possession and in hospitals
• Arrange an appointment with a qualified representative for replacement batteries with improved cells
• Return the affected products to HeartWare Inc. along with the completion form attached with the letter
• Forward the notice to third affected customers

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:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm509214.htm

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

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