FDA Classifies Two Field Actions Related to Medtronic’s HeartWare HVAD System as Class 1 Recalls
September 30, 2016—Medtronic plc announced today that two previously communicated global voluntary recalls related to the HeartWare International HVAD system, a full-support ventricular assist device, have been classified as class 1 by the US Food and Drug Administration (FDA). Class 1 recalls describe situations in which there is reasonable risk of serious adverse health consequences or death.
The HeartWare HVAD system is composed of a mechanical pump and a controller, which is a small computer that monitors the pump. The system is indicated in the United States for refractory end-stage left ventricular heart failure patients who are awaiting a heart transplant. The HVAD system is approved in Europe for long-term use in patients at risk of death from refractory, end-stage heart failure.
In August 2016, Medtronic announced the completion of its acquisition of HeartWare International, Inc., a developer and manufacturer of less-invasive, miniaturized, mechanical circulatory support technologies for treating patients with advanced heart failure. HeartWare is now part of the Heart Failure business within the Medtronic Cardiac Rhythm and Heart Failure division.
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 United States, all clinician notifications have been acknowledged, and globally, 99% of clinician notifications have been acknowledged, advised Medtronic.
According to Medtronic, hospital clinicians were advised to inspect patients’ HVAD HeartWare controllers for loose connectors at the 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, reduce the 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 #1400, Model #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 September 26, this recall and subsequent inspection of patients' controllers have 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 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 United States, all clinician notifications have been acknowledged, and globally, 89% of clinician notifications have been acknowledged.
Clinicians were advised to review hospital inventories for HVAD pump implant kits with serial numbers lower than HW25838 with the following model numbers and notify the company for replacement: Model #1103; Model #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 September 26, 323 of the 350 implant kits (92%) have been used or returned to HeartWare.
Medtronic stated that clinicians with questions should contact their HeartWare representative, call Medtronic HeartWare's 24-hour clinical support line at (888) 494-6365, or email FSCA@heartware.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm. The form can be downloaded at www.fda.gov/MedWatch/getforms.htm or requested by calling (800) 332-1088. The completed form can then be returned to the address on the pre-addressed form or submitted by fax to (800) 332-0178.