FDA deems two HeartWare HVAD recalls as “Class I”

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Medtronic has reported that two previously communicated global voluntary recalls related to the HeartWare HVAD System have been categorised as Class 1 by the FDA. Class 1 recalls describe situations where there is reasonable risk of serious adverse health consequences or death. A press release states that in a safety notification letter distributed globally earlier this year, HeartWare notified physicians regarding potential damage to controllers from exposure to moisture through loose power and data connectors.

The press release adds that, in the USA, all clinician notifications have been acknowledged, and globally 99% 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 sold worldwide: Model No. 1400 and 1401. 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 26 September 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.

Clinicians were advised to review hospital inventories for HVAD implant kits (pumps) with serial numbers lower than HW25838 with the following model number and notify the company for replacement: Model No.  1103 and 1104. At the initiation of this recall, 350 potentially affected HeartWare HVAD implant kits with these model numbers had been distributed and remained in hospital inventories, worldwide. As of 26 September 2016, 323 of the 350 implant kits, or 92%, have been used or returned to HeartWare.

Medtronic acquired HeartWare on 23 August 2016; the combined organisation is committed to putting patient safety and customers first and to implementing manufacturing enhancements to address these issues.

The HVAD System includes a ventricular assist device (VAD), or mechanical pump, that pumps blood to the body when one of the heart’s natural pumps (a ventricle) does not perform well. The controller is a small computer that monitors the pump. These implanted systems can allow people with advanced heart failure to return to a fuller life while they await heart transplantation.