FDA designates VAD recalls as Class 1

Medtronic announced two previously voluntary recalls for a ventricular assist device system have been given a Class 1 classification by the FDA.

A Class 1 designation by the FDA means that the agency classifies the situation as one with “a reasonable risk of serious adverse health consequences or death,” according to a press release issued by the company.

In the release, Medtronic stated that physicians were notified in May and June of 2016 in regards to the loose power connectors and data connectors and the potential damage they could have on controllers of the system (HVAD System, HeartWare International/Medtronic). All U.S. clinician notifications have been acknowledged, as have 99% of global notifications, the company stated.

The initial notifications, affecting 8,799 controllers with model numbers 1400 and 1401, were made by HeartWare International, which at the time was a separate company; Medtronic acquired the company in August.

Damage to controllers could result in loss of communication between the controller and monitor, reduced ability to detect alarms or interruption of circulator support due to pump stop, potentially causing serious injury or death, Medtronic stated in the release.

By Sept. 26, 2016, 308 affected controllers worldwide had been replaced as a result of the recall, according to the release.

Physicians were also advised to review hospital inventories for the use of HVAD implant kits with serial numbers below HW25838, were voluntarily recalled due to the risk of electrical faults and connection failures in the event of fluid entering the driveline-to-controller connector during or after implant, potentially resulting in a pump stop, interrupting circulatory support, which could lead to injury or death, according to the release.

As of Sept. 26, 2016, 92% of the remaining implant kits have been used or returned to HeartWare, according to the release.