Medtronic HeartWare HVAD Instruction Recall Issued Over Safety Concerns
Certain Medtronic HeartWare Ventricular Assist Device (HVAD) Systems have been recalled to update and address a series of instructions and patient start-up manuals, following dozens of injuries and at least one fatality linked to problems with the products.
The FDA announced a Medtronic HVAD System recall on May 12, listing a series of Instructions for Use (IFU) and Patient Manual (PM) changes which have been issued to help prevent accidental disruptions to the pump functionality.
The HeartWare Ventricular Assist Device (HVAD) 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.
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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 either in a hospital setting or during patient transport.
According to the recall notice, Medtronic has become aware of at least 64 injuries and one fatality related to damaged or dropped HVAD carrying cases, incorrect installation of the driveline cover and mistakes occurring during the controller powering-up sequences.
To address the issues, Medtronic has released a series of updates to the device IFU and Patient Manual which instructs patients to keep the driveline cover on when disconnecting and reconnecting the driveline during a controller exchange, in order to prevent an accidental reversed orientation, which could cause temporary or accidental driveline disconnects.
Medtronic has also become aware of injuries arising from mistakes made during the controller power-up sequence. The recall indicates during the power-up process an LED lights turn red and have been misunderstood as a “red alarm”, leading to delays in treatment and unnecessary controller exchanges. The manufacturer will be updating the IFU and PM to make clear that the expected power-up sequence causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the controller LCD displays the power-on message.
The IFU and PM updates will also address issues related to the HVAD Convertible Patient Pack designed to allow patients to wear the devices. Medtronic is warning an accidental drop of the HVAD device while in the Convertible Patient Pack may disconnect the driveline and suddenly interrupt pump power. Medtronic will be releasing updated information regarding the lifespan of the carrying cases and how to properly clean and wear them to avoid interruptions.
Medtronic sent an Urgent Medical Device Notice to all affected customers on February 26, however, the FDA has classified the recall as a Class I recall this week, indicating it is the most serious of its kind and the use of the devices may result is serious patient harm or death.
Customers with questions are being encouraged to contact their Medtronic Field Representative or Medtronic Customer Service at 877-367-4823. Healthcare professionals and consumers are encouraged to report any adverse reactions or quality problems they experience with the devices to the FDA Safety Information and Adverse Reporting Program.
HeartWare HVAD Problems
HeartWare devices have a long history of manufacturing and design defects and have been the subject of numerous recalls. Just last month, the FDA announced a Medtronic Heartware HVAD recall on April 15, indicating the controller and power cabling may be prone to unexpected failure and cause the devices to stop functioning.
In May 2020, Medtronic issued another HeartWare HVAD Class I recall following nearly 100 reports of problems where the strain relief screw broke and outflow graft tore while preparing the device for implant. The recall warned the design defect placed patients at risk of suffering serious injuries, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, and the need for additional medical procedures or death.
In June 2018, Medtronic issued a HeartWare HVAD power failure recall impacting more than 16,000 units that had been implanted in patients as of May 22, 2020. The recall was initiated after Medtronic discovered the electrical connection between the system’s power source, such as the battery, AC adapter, or DC adapter, and the HVAD controller could be interrupted, potentially causing the pump to stop working, resulting in an exacerbation of heart failure symptoms, including weakness, dizziness, anxiety, nausea, loss of consciousness or death.
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