A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The 1st recall is over issues with loose power connectors, which may cause the rear portion of the pump’s driveline connector to become separated from the front portion. A loose connector could allow moisture to entire the controller and cause corrosion, which could cause electrical issues, reduced speaker volume and connection failures.
Lowered speaker volume could limit the ability of the user to hear necessary alarms, and loss of connections could cause the pump to stop, which could lead to adverse health events and death.
All HeartWare controllers are identified in the recall, with product codes 1400, 1401, 1403 and 1407 and manufacturing dates between September 30, 2014 and February 29, 2016. A total of 4,564 units were identified in the FDA’s recall notice.
The company said it notified patients with devices on June 8, instructing them about safe use of the device and to inspect for loose connectors.
If loose connectors are found, the company urged users to replace them with an unaffected controller or to contact their local HeartWare representative.
The 2nd recall is related to design flaws in the driveline connector of the device, which connects the HVAD’s pump to the external controller and power source. The flaw could cause contamination of the driveline which can result in fluid and material entering the pump and causing electrical issues or pump stops.
Electrical issues and pump stops with the device could lead to adverse health consequences and death, according to the company.
A total of 105 units were identified in the recall, which affects all sterile un-implanted stock in inventory with serial numbers prior to HW25838 and product code 1103. The recalled devices were manufactured between July 31, 2014 and March 30, 2016.
Medtronic’s HeartWare said it notified customers of the issue on August 17, and instructed customers to identify affected HVAD devices and return them to the company.
The recalls are only the most recent in a string of recalls for the HVAD systems. Last month, the FDA posted a Class I recall notice for select HVAD controllers over issues with loose power connectors that could stop the pump from functioning.
Medtronic released information on 2 other recalls affecting its HeartWare ventricular assist devices in late September.
The post FDA posts 2 new Class I HeartWare HVAD recalls appeared first on MassDevice.
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