Heartware Ventricular Assist Device Recall Issued Due to Loose Connector Risk
Federal health regulators have announced another recall for Heartware Ventricular Assist Devices (HVADs), indicating that another problem with the medical device could place patient lives at risk.
A HeartWare Ventricular Assist Device Controller recall was announced by the FDA on October 28, indicating that a loose power connector may allow moisture to enter the controller, resulting in electrical issues that could cause the pump to stop working, increasing the risk of adverse health outcomes or death.
The HeartWare Ventricular Assist Device is designed to help pump blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure. These patients use the pump while waiting for a heart transplant. The system includes a pump implanted in the space around the heart and a controller regulating the speed and function of the pump. It is designed to be used both in a hospital setting or during patient transport.
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The loose connector could lead to the rear portion of the pump’s driveline connector to become separated from the front part of the connector. If moisture enters the system, it can result in corrosion, electrical issues, cause the speaker volume to be decreased and cause connection failures. A connection failure could cause the pump to stop, and if the speaker volume is reduced, the patient may not hear the device’s alarm, the FDA warns.
The recall is related to an HVAD Class I recall announced by the FDA on October 21 that affected the pump itself. Again, it dealt with moisture entering the driveline connectors and causing electrical problems.
This recall is targeted at the controllers. Affected units have serial numbers HW001 to WH11270, and HW20001 to HW 20296, and product codes 1100, 1101, 1102, 1103, 1104, and 1205. The controllers were manufactured between March 6, 2006, and October 17, 2016.
The devices were manufactured by HeartWare, Inc.
Both the HVAD and HVAD controller recalls have been designated Class I medical device recalls, meaning that the FDA believes the problems could result in severe injury or deaths of patients.
The company informed customers of the problem with the controller in a letter in June, urging them to warn patients about the potential problem, inspect controllers for loose connectors, and replacing those controllers if the connections were loose.
Healthcare professionals with questions can contact HeartWare through their representative or by email at email@example.com or by phone at 1-877-367-4823.
Heartware’s History of Recalls
HeartWare has a long history of being affected by faulty devices and numerous recalls. The company was involved with another class I recall last year which affected more than 1,700 units across the U.S. During that recall, the Ventricular Assist Systems malfunctioned due to bent pins in a faulty power supply connector port. The company received at least 33 reports of device malfunction, including one non-fatal injury.
Another recall was issued for the HeartWare device in August 2015. The recall was issued after reports of bleeds, blood clot complications, strokes and other injuries were linked to the devices. HeartWare reported they were conducting clinical trials to better evaluate the safety of their devices, yet continue to experience problems.
HeartWare VADs were affected by another recall in 2014. The devices were recalled after a defect caused two deaths and four serious injuries. That recall was also initiated because of a defective driveline connector.
HeartWare was accused of dropping the ball on fixing the issues. Three years prior to the recall, HeartWare received at least 27 complaints about the controller of the pumps.
Users and customers affected by the most recent recall or who have experienced adverse health effects can contact the FDA via the MedWatch Adverse Event Reporting Program online or at 800-FDA-0178.
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