Recall Class: Class I
Dates Recall Initiated: April 29, 2015
Device: HeartWare Ventricular Assist Device (HVAD)
- Product Codes: 1101, 1103
- Serial Numbers: All Heartware systems currently in use
- Manufacturing and Distribution Dates: January 2008 to March 2015
- Devices recalled in the US: 1763
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.
14400 NW 60th Avenue
Miami Lakes, Florida, 33014
Heartware recently conducted five recalls for this device. They are all outlined in the firm’s June 8, 2015 press release . The FDA will update this page as new information becomes available.
HeartWare Ventricular Assist System - Damaged Alignment Guides / Connection Pins May Cause Pump to Stop (Added 6/16/2015)
The alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their HVAD. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death.
The company has reported 33 reports of malfunction and one serious injury related to this problem.
Battery Failure May Prevent Alarm from Sounding (Added 6/19/2015)
The battery that powers an alarm in the controller may fail over time. If the battery fails, the alarm will not alert the patient in the event that both external power sources for the HVAD are disconnected.
The HVAD should never be disconnected from both power sources at the same time because the pump will stop working. If a pump stop occurs, the potential risk for the patient ranges from minimal temporary symptoms of hypoperfusion to cardiopulmonary arrest and death.
The firm has received a total of four reports of incidents in which the device has malfunctioned, including three injuries and one death.
Damage to Driveline Connector May Cause Electrical Issues or Pump Stops (Added 6/19/2015)
Damage to the driveline connector may occur if the driveline is pulled too often with too much force. The driveline is a tube that connects the HVAD’s pump to the external controller and power source. Severe damage or disconnection of the driveline from the controller can cause electrical issues or pump stops that may lead to serious patient injury or death.
The firm has received a total of three reports, including one serious injury and two reports of death related to damage to this issue.
- Patients with questions about this recall should contact their health care provider or the HVAD Coordinator at their hospital center.
- Health care providers who have questions should contact their HeartWare representative or contact HeartWare’s 24-hour Clinical Support at 1-888-494-6365, or email FSCA@heartware.com.
FDA District: Florida District Office
More Information about these Recalls:
Heartware sent their customers an Urgent Medical Device Correction notice on May 11, 2015 to alert them of the problem and actions to take. Heartware will replace all defective controllers by the end of June 2016.
Health Care Providers:
- Forward HeartWare’s voluntary safety notice to those individuals within your organization who need to be aware of its content.
- Identify the patients currently supported by the HVAD System.
- Distribute the patient communication to those patients directly by FedEx or other traceable communication method. Contact your HeartWare representative for any assistance with this process.
- Make appointments to see the patients subject to this recall as soon as possible, and inspect their device’s power supply connector ports for wear, twisting, or bending. Consider replacing the controller if necessary.
- Continue to reinforce the messages described in HeartWare’s voluntary safety notice with your patients during their regularly scheduled appointments.
- Complete, sign, and return the “Acknowledgement and Completion Form” to your HeartWare representative within 30 days of receipt of this letter or by email at FSCA@heartware.com.
HeartWare provided the following reminders for patients:
- Never disconnect from both power sources at the same time.
- Take care when connecting to power sources.
- Keep the outer sheath of your driveline protected from excessive sunlight.
- Beware of accidental snagging or pulling of your driveline.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.