HeartWare Ventricular Assist Device Controller, a small computer that monitors the pump (Credit: U.S. FDA)
Recalled Product:
- HeartWare Ventricular Assist Device (HVAD) Controllers
- Serial Numbers: All HeartWare Controllers
- Product Codes: 1400, 1401, 1403, 1407
- Manufacturing Dates: September 30, 2014 to February 29, 2016
- Number of devices manufactured: 4586
- Devices Recalled in the U.S.: 91 units distributed nationwide
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.
The HVAD is designed for use both in and out of hospital settings, including during patient transport.
Reason for Recall
HeartWare Inc. is recalling the HVAD controller due to a loose power connector which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death.
HeartWare issued a related recall for the HVAD on July 29, 2016.
Who May be Affected
- Patients receiving cardiac support using the HVAD system
- Health care providers and caregivers monitoring patients with a HVAD system
What to Do
On June 8, 2016, HeartWare Inc. sent an “Urgent Medical Device Correction” letter to affected customers. The letter instructed providers who care for these patients to:
- Remind patients about the safe use of the HVAD System, particularly with regard to moisture and proper connection to power and data sources.
- Inspect controllers for loose connectors by gently pressing on each connector and feeling for atypical movement.
- If a loose connector is identified, replace with a controller from inventory and contact your local HeartWare representative
- If the loose controller is the patient’s primary controller, perform a careful benefit risk analysis before using the device.
- Sign and return the “Acknowledgement Form” to HeartWare Quality Compliance via email at FSCA@heartware.com, or fax it to (305) 364-2665 within 30 days.
