Medtronic HeartWare System Has Faced Multiple Class I Recalls and Adverse Device Event Reports Since 2012 PMA

Medtronic's HeartWare HVAD pump system has faced a series of recalls in recent months. FDA databases show that the system has a higher rate of device malfunction reports since its market introduction compared to similar competing products.

So far this year, the FDA has issued three Class I recalls for the system, involving restart delays or stalls and updates to instructions for use. However, the system's problems can be traced back to shortly after it received FDA premarket approval (PMA) in 2012—about four years before Medtronic acquired the product through its $1.1 billion purchase of HeartWare International.

This series of recalls, coupled with a lack of clarity regarding causation and the fragmented nature of available data, highlights the piecemeal system the FDA uses to monitor medical device safety. Both industry and regulators acknowledge that reporting data is incomplete, may contain duplicates, and may underreport criteria such as injuries or deaths.

Even so, independent experts say the trend warrants further investigation.

Medtronic said in an emailed statement that it is evaluating the system and "implementing a robust corrective action plan." The company is "in regular communication with the FDA to ensure transparency as we work to improve performance and mitigate device performance issues."

Medtronic did not comment on the specific steps the company is taking to improve the system.

Since 2013, the FDA has issued 13 Class I recall notices for the HeartWare HVAD system. Several of these are extensions of previous recall notices, while others involve multiple affected components and multiple issues within the same recall. Two recalls are related to the HVAD system but are not direct components of the pump, such as repair kits for system components, and the most recent one involving updates to instructions for use and patient manuals.

Reasons for the recalls range from electrostatic discharge causing pump failure in 2015, an unintended electrical disconnection between the power source and the pump controller in 2018, and a recall in April of this year involving multiple batteries, data cables, and adapter cables.

Some recalls and issues predate Medtronic's 2016 acquisition of HeartWare; however, 9 of the 13 recall notices for the HVAD system were issued after the medical device giant completed the acquisition.

According to FDA data, the three Class I recalls for Medtronic's HeartWare HVAD system in 2021 collectively involved 91 injury reports and 15 death reports.

Medtronic's calculation of the total number of death reports related to the April recall differs. The company believes that as of January 7, compared to the 12 deaths the FDA attributed to these issues, there was actually 1 death related to the issues, 7 possibly related, and 3 unrelated.

Before 2020, FDA recall notices for the system did not provide data on deaths and injury reports.

The Question of Cause

The HeartWare HVAD system is a medical device that helps pump blood in patients with heart failure. The system includes an implantable pump and a non-implantable controller, and is a Class III medical device, meaning it carries higher risk and may pose a significant risk of injury.

This device and other ventricular assist devices are typically used in critically ill patients or those at risk of death. Similar products include Abbott Laboratories' HeartMate II left ventricular assist system and the company's HeartMate 3.

Although all three devices have experienced multiple recalls of their system components, at least from public data, Medtronic's HeartWare has a higher recall frequency than the other two products.

An analysis by the regulatory watchdog ECRI of the FDA recall database (which is separate from FDA recall notices, as the database lists individual component or part recalls that may involve only one notice) shows that from the system's PMA approval in November 2012 through April of this year, the HeartWare HVAD system experienced 27 Class I recalls and 8 Class II recalls.

In comparison, Abbott's HeartMate II system experienced 8 Class I recalls and 3 Class II recalls from its PMA approval in April 2008 through April of this year; HeartMate 3 experienced 1 Class I recall and 4 Class II recalls from its PMA approval in August 2017 through April of this year.

Chris Lavanchy, engineering director at ECRI, said it is challenging to determine the overall problem of a product just by looking at the number of recalls, and understanding the reasons for the recalls is crucial.

"(The recalls) could be software changes they made, or they could be issues with cables and mechanical parts. So, it's very important to understand the whole history," Lavanchy said.

Recalls are primarily initiated voluntarily by manufacturers. The reasons also vary, from device stoppage to updates to instructions for use. However, Class I recalls are the FDA's most serious designation because continued use of the device could lead to serious injury or death.

Madris Kinard, CEO of Device Events (an organization that compiles and interprets FDA medical device reports and recall information), said that numerous recalls involving different components of a device should trigger a review of the entire system, but the FDA may not always do so.

"Do these piecemeal recalls—when you add them all together—mean there's a bigger problem with the whole device, not just with each component?" said Kinard, a former FDA staff member.

The FDA said in a statement that if a device experiences multiple recalls in a short period, the FDA can work with the manufacturer to conduct further safety reviews, design changes, or product label updates.

The FDA did not specifically comment on whether the agency is working with Medtronic on a comprehensive product review of the HeartWare system or any potential changes.

Although the FDA has previously suspended marketing of products with a series of safety issues and initiated further safety reviews (recent examples include breast implant products), Kinard said, "The FDA doesn't do that very often."

Device Malfunction Reports

In addition to tracking recalls issued by manufacturers, the FDA maintains a database that records events of patient injury, death, or device malfunction. The Manufacturer and User Facility Device Experience (MAUDE) database stores medical device reports submitted by mandatory reporters (manufacturers, importers, and device user facilities) as well as voluntary reporters such as healthcare professionals, patients, and consumers.

The FDA acknowledges limitations in MAUDE, noting that reports may be incomplete or inaccurate, may contain duplicates, or there is a possibility of underreporting events. Nevertheless, the database can provide insight into safety issues for specific devices and products.

ECRI's analysis of MAUDE shows that since the systems received PMA approval, the HeartWare HVAD system and Abbott's competing products have generated hundreds to thousands of injury and death reports.

However, the HeartWare HVAD system has a higher rate of malfunction reports (relative to total reports).

Since the device received PMA approval in 2012, device malfunction reports have accounted for about 44% of total reports. Since HeartMate II received PMA approval in 2008, malfunction reports have accounted for 15% of total reports; since HeartMate 3 received PMA approval in 2017, malfunction reports have accounted for 4% of total reports.

Year-by-year breakdown data shows that since Medtronic acquired the HeartWare device in 2016, the proportion of malfunction reports has declined—malfunction reports as a percentage of total reports peaked at 74% and 68% in 2015 and 2017, respectively, but have fallen to 34% and 29% in 2020 and so far in 2021, respectively.

Mike Argentieri, vice president of technology and safety at ECRI, said malfunction reports indicate there may be a larger problem with the device, but the data alone is insufficient to make that determination.

According to Argentieri, ECRI would need to actually investigate the product and communicate with the manufacturer and hospitals that reported issues to make a more definitive determination about device safety problems.

"It's hard to draw causal conclusions by looking at a database, any database, even the recall (database)," Argentieri said. "The signal prompts you to look at the issue more closely, at the physical level, and that's when action can be driven."

Lavanchy said that none of the hospitals ECRI works with have reported issues with Medtronic's HeartWare device.