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

Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
Technology | Ventricular Assist Devices (VAD) | July 17, 2018
Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach...
CorWave's Next-generation Neptune LVAD Receives Funding

Image courtesy of CorWave

News | Ventricular Assist Devices (VAD) | July 11, 2018
French-based CorWave announced that its CALYPSO program has received 14 million euros to develop CorWave Neptune, a new...
Abbott Recalls the HeartMate 3 Left Ventricular Assist System, LVAD
News | Ventricular Assist Devices (VAD) | May 23, 2018
Abbott has initiated a Class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the...
FDA Approves Abiomed Impella CP With SmartAssist and Optical Sensor
Technology | Ventricular Assist Devices (VAD) | April 02, 2018
Abiomed Inc. announced that it received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its...
Reduced Device Clotting, Decreased Strokes Seen With HeartMate 3 at Two Years
News | Ventricular Assist Devices (VAD) | March 13, 2018
At two years of follow-up, severely ill patients with advanced heart failure who received a novel heart pump fully...
Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD) | September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD) | August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD) | June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Overlay Init