The FDA today posted a Class I recall notice for select Medtronic (NYSE:MDT) HeartWare ventricular assist device controllers over issues with loose power connectors that could stop the pump from functioning.
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 agency identified issues with loose power connectors which could cause the rear portion of the pump’s driveline connector to become separated from the front portion of the connector.
“A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death,” the FDA wrote in its recall notice.
The recall affects approximately 4,586 units worldwide, with 91 units within the U.S. Serial numbers HW001 to HW11270 and HW20001 to HW20296 were identified in the recall, with product codes 1100, 1101, 1102, 1103, 1104 and 1205. The recalled units were manufactured between March 6, 2006 and October 17, 2016.
The FDA said that on June 8, HeartWare sent an urgent medical device correction letter to affected customers, instructing them to inspect controllers for loose connectors and feeling for atypical movement, and to replace any affected units with new controllers.
Medtronic released information on 2 other recalls affecting its HeartWare ventricular assist devices in late September.
The voluntary recall is related to potential damage to controllers on the device from exposure to moisture, caused by loose power and data connectors, according to a Medtronic press release. The company added that, in the U.S., all clinicians have been notified and acknowledged, while 99% of clinician notifications have been acknowledged globally.
In a warning sent in May and June, HeartWare advised hospital clinicians to inspect HVAD HeartWare controllers for loose connectors during scheduled appointments, and to replace affected controllers with new equipment when necessary. Clinicians were also instructed to communicate safe use instructions for the HVAD system, with a focus on moisture and proper connection to power and data sources.
Medtronic closed its $1.1 billion acquisition of HeartWare in late August.