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HeartWare Inc. Extends Recall - Ventricular Assist Device

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K9 Mama

Posts : 34
Join date : 2016-06-25

HeartWare Inc. Extends Recall - Ventricular Assist Device

Post by K9 Mama on Sun Jul 03, 2016 11:40 am

Medical Device Recalls > HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product:

   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
   Distribution dates: May 21, 2013 to July 31, 2015
   Devices recalled in the U.S.: 18,631 units nationwide, including Washington D.C.

Device Use

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.
Reason for Recall

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.
Who May be Affected

   Patients receiving cardiac support using the HVAD system supplied with the defective batteries
   Health care providers and caregivers monitoring patients with a HVAD system supplied with the defective batteries

What to Do

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

Contact Information

Customers can contact HeartWare Inc. at <cs@heartware.com> or via telephone by calling 1-877-367-4823.
Date Recall Initiated:

January 7, 2016
Additional Resources

   HeartWare Ventricular Assist System (VAS) – Electrostatic Discharge May Cause Pump Failure (February 2015)
   HeartWare Ventricular Assist System – Updated with Multiple Reasons for Recalls (April 2015)

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

RESOURCE:http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm509185.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery


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