A Class I medical device recall has been issued by Medtronic for certain HeartWare Ventricular Assist Device (HVAD) cardiac devices, after the manufacturer recognized that a screw may break or tear during assembly before it is implanted, resulting in a delay in treatment that could cause serious and potentially life threatening complications.
The Medtronic HeartWare HVAD recall was announced by the FDA on May 28, following nearly 100 reports of problems where the strain relief screw broke and outflow graft tore while preparing the device for implant. To date, no deaths have been associated with the impacted products, but the class I designation indicates that continued use of the product may result in severe adverse events.
The HeartWare Ventricular Assist Device (HVAD) is a pump that helps the heart deliver blood to the rest of an individual’s body, and is typically used as a bridge to cardiac transplant for patients at risk of left ventricular heart failure. It is used on patients both in the hospital and out of the facility, such as when a patient is being transported via aircraft or helicopter.
According to the recall, the Medtronic HVAD contains a defect that may allow the outflow graft of the Pump to tear and the strain relief screw to break during assembly, prior to implant. Officials have indicated these defects may not be identified during or after they are attached to the HVAD pump, which may result in failure to perform and delay life-saving treatment.
The problem places patients at risk of suffering serious injuries, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, the need for additional medical procedures and death.
The recall impacts at least 4,924 HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief systems with model numbers 1125, 1103 and 1153 manufactured by Medtronic and distributed to medical facilities across the U.S. from March 1, 2018 to April 1, 2020.
Medtronic initiated the recall on April 3, 2020 and issued a Medical Device Safety Alert to all affected customers, instructing them to closely inspect the graft after assembly and before implantation and to practice standard pre-operative and immediate post-operative patient management to look for this issue.
After receiving 92 reports of the strain relief screw breaking or the outflow graft tearing, the FDA upgraded the Medical Device Safety Alert to a Class I recall, indicating it is the most serious of its kind, and that a risk of serious injury or death could result from the use of the products.
Customers with impacted devices are being asked to complete a Physician Confirmation Form sent on April 3, 2020, and either return it to your Field Representative or email to RS.CFQFCA@medtronic.com to indicate you received the notification.
Medtronic has experienced a variety of issues with HeartWare HVAD models, resulting in at least two recalls in recent years. In 2018, Medtronic issued a HeartWare HVAD recall involving more than 16,000 devices after discovering 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. Officials warned this may cause the pump to stop working, resulting in an exacerbation of heart failure symptoms, including weakness, dizziness, anxiety, nausea, loss of consciousness or death.
In 2017, Medtronic issued another Class I recall for HVAD System Controllers due to the devices experiencing battery failure, power and data failures, and premature wearing of the alignment guides. That recall resulted in at least two deaths, four serious injuries and 27 field reports of other failures and problems regarding the devices.