News | May 07, 2014

HeartWare Intl. Issues Voluntary Device Correction For HeartWare Batteries

HeartWare Ltd. Ventricular Assist Device Correction Batteries

May 7, 2014 — HeartWare Intl. Inc. issued a voluntary Urgent Medical Device Correction related to all HeartWare Ventricular Assist System batteries, product codes 1650 and 1650-DE. In letters to clinicians and patients, the company reports an observed increase in complaints related to earlier-than-expected battery depletion and routine battery handling.

HeartWare is providing information to assist patients and clinicians in monitoring battery performance, recognizing abnormal behaviors and reinforcing proper power management. Premature or unrecognized deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. If a battery shows abnormal behavior, patients are instructed to stop using that battery and contact their ventricular assist device (VAD) coordinator for a replacement.

Similar to the battery in a mobile cell phone, HeartWare batteries will begin to lose charge over time. If a fully-charged battery lasts less than two hours or if the controller switches back-and-forth between batteries, patients are asked to take the affected battery out of service and replace it with a new one.

No deaths have been reported to HeartWare that were directly related to a faulty battery. However, between Jan. 1, 2011 and March 31, 2014, three deaths were reported that were potentially related to power source management. Of those, two patient deaths occurred after both sources of power were simultaneously disconnected; the third patient had batteries that far exceeded their expected useful life. A fourth death was originally reported as possibly related to power management, but was later determined to be more likely related to an accidental disconnection of the driveline.

Clinicians and patients are encouraged to review the correction letters and the Patient Manual to ensure proper power management.

Patients with questions about this announcement should contact their physician or VAD coordinator at their hospital center. Clinicians with questions related to the correction should contact their HeartWare representative or HeartWare's 24-hour Clinical Support line at 888.494.6365 or via email at [email protected]

Adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 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 800.332.0178

For more information: www.heartware.com

Related Content

Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Aug.
Wearable monitors create patient generated health data, PGHD, that can help prevent acute care episodes in heart failure.

Wearable monitoring devices may offer a new tool to help prevent acute care episodes in heart failure.

Feature | Heart Failure| July 25, 2017 | Lola Koktysh
Despite their best efforts, many patients tend to develop heart failure after an acute event (e.g., a heart attack or
Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT)| July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Hospital Readmissions Analysis Across All Ages, Insurance Types Identifies High-Risk Groups
News | Business| July 20, 2017
July 20, 2017 — Clinician-researchers at Beth Israel Deaconess Medical Center (BIDMC) recently published a first-of-i
Sponsored Content | Videos | Cardiovascular Ultrasound| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients
News | Heart Failure| July 14, 2017
A review appearing in the July 18 issue of the Journal of the American College of Cardiology (JACC) discusses current...
Sponsored Content | Videos | Heart Failure| July 13, 2017
William Abraham, M.D., director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medica
Overlay Init