FDA Classifies Latest HeartWare VAD Recalls as Class I
For the affected units being recalled, there is a concern moisture could enter the driveline-to-connector controller and result in pump stoppage.
The US Food and Drug Administration (FDA) is notifying physicians of a Class I recall of unimplanted HeartWare ventricular assist device (VAD) implant kits, initiated voluntarily by the company in August 2016, because the VADs might be susceptible to electrical issues or connection failures that result in serious adverse health outcomes, including death.
The FDA states there are design problems with the driveline connector, which may result in fluid and other material entering the VAD pump once implanted. If fluid enters the driveline-to-controller connector during or after the implantation procedure, electrical problems could result in pump stoppages.
Physicians were first warned of the issue in August via an “Urgent Medical Device Recall Letter” sent by HeartWare, with physicians asked to identify affected VADs in hospital inventory and return all products to HeartWare. According to the company, all clinician notifications in the United States have been acknowledged.
There were 105 units distributed in the US and 350 distributed worldwide that are subject to the voluntary recall, and 323 have already been returned to HeartWare as of late September.
Earlier this year, HeartWare also warned physicians to inspect the VAD controller for loose connectors during patient appointments and to replace affected controllers if needed. The loose connection might result in the loss of communication between the controller and monitor. The problem, which also resulted in a class 1 safety notification and recall of affected devices, could result in a reduced ability to detect alarms of interruptions of support with pump stoppage and lead to serious injury or death.
January 2016, HeartWare sent an urgent letter warning physicians the VAD could fail because of premature battery depletion due to faulty cells.
Medtronic acquired HeartWare in a $1.1 billion dollar deal in August 2016. The combined organizations are working to address the VAD issues, according to a statement released by HeartWare.
HeartWare. FDA classifies two field actions related to HeartWare HVAD system as Class 1 recalls. http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle_Print&ID=2207145. Published on: September 30, 2016. Accessed on: October 24, 2016.
US Food and Drug Administration. HeartWare recalls ventricular assist device pumps due to contamination causing electrical issues. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm526212.htm. Published on: October 21, 2016. Accessed on: October 24, 2016.