HeartWare Ventricular Assist System Recall: Bent Pins Could Lead To Death
A Class I recall has been initiated for more than 1,700 HeartWare Ventricular Assist Systems (VAS), due to the risk that the power supply connector ports may wear down over time, which could prevent the device controller from connecting to the VAS, posing a serious risk of patient injury or death if an electrical failure causes the pump to stop.
The HeartWare Ventricular Assist System recall was announced by the FDA this week, following at least 33 reports of device malfunction, including at least one serious, but non-fatal, injury related to the connection failure problems. The FDA has categorized this action as a Class I recall, indicating there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.
The Ventricular Assist Systems being recalled are devices used in patients who are waiting for a heart transplant and are at risk of death from end-stage left ventricular heart failure. The systems are designed to pump blood from the heart to the rest of the body by implanting a pump in the space around the heart. The system includes a controller that controls the speed and function of the pump to accommodate the individual’s needs.
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The FDA categorized this device recall as a Class I due to the severity of injuries that could result from an electrical shortage causing the pump to shut off. To date, patients have reported the alignment guides in the power supply connector ports have worn down over time causing the connection pins to become twisted or bent. This may eventually prevent the patient from connecting the device controller to the VAS. In the event the patient cannot connect the device controller to the VAS, an electrical connection failure can occur, causing the pump to stop and preventing the control of blood flow.
The devices being recalled include all HeartWare Ventricular Assist Systems with product codes 1101 and 1103. The devices were manufactured by HeartWare of Miami Lakes, Florida where they were sold to healthcare providers nationwide from January 2008 to March 2015.
HeartWare issued an Urgent Medical Device Correction notice to their customers on May 25, 2015, alerting them of the device issues and corrective actions to be taken. HeartWare announced in the notice the company will replace the defective controllers to prevent electrical failures by the end of June 2016.
The corrective action is calling for all health care providers to identify patients with impacted VAS’s and distribute the included patient communication to those individuals immediately via traceable mail informing them to make appointments as soon as possible. Healthcare providers are to inspect the device’s power supply connector parts for wear, twisting, or bending and consider and consult with patients whether replacing the controller.
Other HeartWare Problems
This is not HeartWare’s first blood pump assist recall. In July 2014, the company recalled their Ventricular Assist Device after 2 people died and 4 were seriously injured from the driveline connector locking mechanism on the device failing to engage the unit, causing the unit to fail and stop pumping.
The fatality and injury reports prompted FDA investigators to initiate an investigation which found a number of deficiencies at the HeartWare Miami Lakes, Florida, facility, particularly involving the manufacturer’s process for making sure that some corrections made to the HVAD actually work.
The FDA issued a warning letter to HeartWare in June 2014 following the inspection that stated the company’s response to the HeartWare VAD problems have been inadequate, and did not meet current good manufacturing practice (cGMP) requirements for medical devices.
Healthcare providers with further questions or concerns regarding the recall should contact HeartWare’s 24-hour Clinical Support at 1-888-494-6365 or email them at FSCA@heartware.com. Patients and healthcare providers are being encouraged by the FDA to report adverse reactions or quality problems related to the VAS and VAD systems to the agency’s online reporting program MedWatch.
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