Medtronic HeartWare Recalls: A Guide for Attorneys

In April 2020, Medtronic sent out a safety alert to physicians and healthcare professionals warning them of dangers with the HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief devices. The following month, the U.S. Food and Drug Administration issued a Class I recall, the most serious type of recall, of the devices, citing the potential for serious injuries or death. Likewise, in December 2020, Medtronic sent out another alert, this time for its HVAD Pump Implant Kit, after receiving complaints of serious injuries and deaths. In March 2021, the FDA issued another Class I recall on the kits.

Medtronic’s HeartWare products are ventricular assist devices—mechanical pumps that support the heart and blood flow for those with weakened hearts. The devices are surgically implanted and connected to an external control unit. Last year’s recall of Medtronic’s HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief devices was issued because it was discovered that the outflow graft of the HVAD Pump may tear and the strain relief screw may break during assembly. The defect, however, might not be observed until during or after the pre-implant pump assembly and attachment to the HVAD pump. Medtronic’s letter to physicians provided additional steps for assembly and attachment to reduce the risk of damage during the assembly procedure, stressing that no further action is needed for patients already implanted with the pump since the damage applies to the pre-implant procedure.

Out of approximately the 22,000 HVAD pumps distributed through March 5, 2020, Medtronic had received 92 complaints related to the pre-implant assembly process and the associated outflow graft tears and strain relief screw damage. Complications related to outflow graft tears resulted in 54 complaints, including two deaths, resulting from peri-operative and post-operative bleeding. There were 38 complaints related to broken strain relief screws, with product damage identified prior or during the implant in 74 cases and post-implant in 18 cases. No harm related to damaged strain relief screws were yet reported. According to the FDA, the use of these defective products can cause dizziness, loss of consciousness, bleeding, fluid buildup around the heart, the need for additional medical procedures, and/or death.

By December 2020, Medtronic announced another potential danger, this time with its HVAD Pump Implant Kits, due to the device failing to start, restate, or delay in restarting once the pump stops. Medtronic sent out letters instructing health care providers how to avoid unnecessary pump stops and informing patients to contact their Ventricular Assist Device coordinator prior to any controller exchanges of the device. According to the FDA’s recently issued Class I recall, the delay or failure of these kits to start or restart can occur at any time – during preimplant testing, during the implant, or post-implant, and could cause serious harm such as heart attack, worsening heart failure, the need for additional procedures and hospitalizations, and/or death. There have been 29 complaints about this issue, with two deaths reported.

The severity of these recalls and the potential dangers of Medtronic products leave the issue ripe for mass tort litigation. Although no lawsuits specific to these products have been filed just yet, attorneys have certainly expressed their interest in filing suits on behalf of those affected. And if prior Medtronic lawsuits are any indicator—such as its $54.5 million settlement reached in November 2018 to resolve allegations that it misled its investors about the safety of its heart pumps—it is likely any future litigation will be both complex and costly.

For attorneys interested in representing potential plaintiffs, Expert Institute offers services to make complex litigation easier. Our strategic research service provides an in-depth report on the device in question, including a comprehensive overview of the product’s history, development, and risk factors for injury. With access to relevant studies and research publications of leading industry experts, attorneys have all the necessary resources to make an informed decision about how to proceed with any potential case.

Expert Institute also offers the Mass Tort Accelerator service which helps attorneys evaluate and strategize their intake procedures for potential plaintiffs in multi-plaintiff, large-scale cases. Attorneys can commission a bespoke client intake rubric to comprehensively assess injuries, detect risk factors, and evaluate each client’s eligibility. A custom intake rubric will also help attorneys identify any missing medical records—all before taking on their case. Our physicians are also available to aid with the evaluation of each plaintiff case’s strengths, weaknesses, and potential outcomes. Through these comprehensive consultative tools, attorneys have the informed guidance to zero-in on the most meritorious case for the purposes of a bellwether trial. This type of careful evaluation of plaintiff cases will be especially valuable for a mass tort on the scale of future Medtronic litigation.