FDA classifies two field actions related to HeartWare HVAD system as class 1 recalls

Medtronic announced that two previously communicated global voluntary recalls related to the HeartWare International (HeartWare) HVAD System have been classified as Class 1 by the U.S. Food and Drug Administration (FDA).

Class 1 recalls describe situations where there is reasonable risk of serious adverse health consequences or death.

In a safety notification letter distributed globally in May and June 2016, HeartWare® notified physicians regarding potential damage to controllers from exposure to moisture through loose power and data connectors.

In the U.S., all clinician notifications have been acknowledged, and globally 99 percent of clinician notifications have been acknowledged.

Hospital clinicians were advised to inspect patients' HVAD HeartWare Controllers for loose connectors at patients' regularly scheduled appointments and to replace affected controllers with a new controller at the clinicians' discretion. Clinicians also were advised to remind patients about the safe use of the HVAD System, particularly with regard to moisture and proper connection to power and data sources.

Damage to the controllers from this issue could cause loss of communication between the controller and monitor, reduced ability to detect alarms or interruption of circulatory support due to pump stop, which could lead to serious injury or death.

HeartWare controllers subject to this safety notification include the following models, 1400 and 1401, sold worldwide.

At the initiation of this recall, approximately 8,799 potentially affected HVAD HeartWare Controllers with these model numbers had been distributed and remained in use by patients, worldwide.

As of Sept. 26, 2016, this recall and subsequent inspection of patients' controllers has resulted in the replacement of 308 affected HVAD controllers worldwide.

In August 2016, HeartWare issued a global voluntary recall of certain models of unimplanted, sterile HVAD® Pump Implant Kits (pumps) in hospital inventory. The HVAD pumps contained in these sterile implant kits may be susceptible to electrical faults and connection failures if fluid enters the driveline-to-controller connector during or after the implant procedure.

Electrical faults or connection failures could interrupt circulatory support due to a pump stop, potentially resulting in serious injury or death. In the U.S., all clinician notifications have been acknowledged, and globally 89 percent of clinician notifications have been acknowledged.