On May 4, 2017, Medtronic expanded its recall of its HeartWare Ventricular Assist Device (HVAD) to include an additional product code. Medtronic also issued instructions to exchange recalled products.
The company recalled 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.
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). It also includes a driveline cable that goes through the skin. The driveline connects the pump to an external controller that regulates the speed and function of the pump. The system is powered with batteries or power adapters. The HVAD is designed for use both in and out of hospital settings, including during patient transport.
Since the issuance of the November 2016 recall, Medtronic Mechanical Circulatory Support has developed an updated HVAD controller, as well as power management software to address the power connector issues.
All serial numbers of the Medtronic HVAD controllers are affected by this recall. Products affected by this recall display product codes1400, 1401, 1403, 1407, and the additional code 1435 for the HVAD DC adapter. The recalled HVAD controllers were manufactured between March 1, 2006, and December 1, 2016, and were distributed between October 11, 2006, and December 1, 2016.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
The following day, May 5, 2017, Medtronic recalled its HeartWare Splice Kit intended to repair the driveline of its HVAD. Medtronic recalled the driveline splice kit due to a design problem that would prevent the repaired cable assembly from withstanding excessive force or pull (e.g., accidental dropping of controllers or snagging driveline cables). The excessive force or pull could cause damage to the cable assembly and interrupt electrical connection. The company issued these kits between April 2010 and March 2015 to repair previous HVAD driveline cable connector assembly issues. The driveline splice kit is intended to repair the driveline once an electrical break has been identified. These repairs are limited to the section of the driveline that is outside of the patient.
An interruption in electrical connection may cause the pump to stop, which may lead to serious adverse health consequences, including death.
See the FDA Safety Alert regarding the HVAD recall
See the FDA Safety Alert regarding the splice kit
See also Medical Law Perspectives, July 2015 Report: Organ Transplants: Saving Lives, Facing Risks, Minimizing Complications
See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues