May 5, 2017 — Medtronic Mechanical Circulatory Support is expanding its recall of its HeartWare Ventricular Assist Device (HVAD) system to include an additional product code and instructions to exchange recalled products. The company originally recalled the VAD system in November 2016 recall due to issues with its controller and power connector issues. Additionally, Medtronic announced a new related recall for the HeartWare splice kit intended to repair the HVAD driveline because it may cause electrical issues or stop the pump. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
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 U.S. Food and Drug Administration (FDA) said in the recall alert.
Since the issuance of the November 2016 recall, Medtronic Mechanical Circulatory Support has developed an updated HVAD controller and power management software to address the power connector issues.
The issue include all heartWare controllers. This includes product codes: 1400, 1401, 1403, 1407 and the additional code 1435 for the HVAD DC adapter. These were manufactured between March 1, 2006 to Dec. 1, 2016 and were distributed between Oct. 11, 2006 to Dec. 1, 2016.
The HeartWare VAD 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.
Recommendations to Hospitals
Medtronic and the FDA said facilities should review the notice and forms, and forward the notice to other staff within their organizations for their awareness. They should then complete, sign and return the acknowledgement form to Medtronic Mechanical Circulatory Support within 30 days of receipt of the letter.
Complete training that will cover the new product labeling including the instructions for use and patient manual.
Hospitals should quarantine and replace affected HVAD controllers, DC adapters, instructions for use, emergency responder guides and patient manuals in hospital inventory after training is complete. These items should be returned to Medtronic. Once the affected product in inventory has been identified and returned, complete and return the “completion form” and send to [email protected] or the Medtronic Mechanical Circulatory Support representative no later than 12 months from the date of the letter according to the instructions on the form.
They also should notify and schedule each of their patients as soon as possible for an appointment to exchange their controllers.
New HVAD Driveline Splice Kit Recall
Medtronic announced March 10 it is recalling 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.
An interruption in electrical connection may cause the pump to stop, which may lead to serious adverse health consequences, including death.
The recall includes all driveline splice repair kits that were used prior to April 2015 includes product codes ASY00116 and ASY00281. These were distributed between Jan. 11, 2011 to May 23, 2014. This includes 9 devices in the U.S.
HeartWare VAD 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). 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.
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.