Medtronic HeartWare system hit with slew of Class I recalls, device reports since 2012 PMA

Medtronic’s HeartWare HVAD pump system has been hit with a slew of recalls in recent months and the rate of device malfunction reports documented since it’s been on the market in an FDA database outpaces competing products.

So far this year, the FDA issued three Class I recalls for the system, including issues with delayed or stalled restarts and updates to instructions for use. However, issues with the system go back to nearly as early as the product received its premarket approval from the FDA in 2012, about four years before Medtronic acquired the product through its $1.1 billion buy up of HeartWare International.

The string of recalls — and lack of clarity on causality and disparate nature of available data — underscores the patchwork system used by the FDA to monitor the safety of medical devices. Both industry and regulators acknowledge the reporting data is incomplete, may be duplicative or criteria like injuries and deaths could also be under-reported. 

Still, independent experts said the trend is worth further exploring.

Medtronic is evaluating the system and “implementing robust corrective action plans,” according to an emailed statement. The company is “regularly communicating with the FDA to ensure transparency with them as we work to improve performance and mitigate against device performance issues.”

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

Since 2013, 13 Class I recall notices have been put out by the FDA involving the HeartWare HVAD System. Several were expansions of prior recalls published by the agency, while others outlined multiple parts affected and issues within an individual recall. Two recalls were related to the HVAD system but not direct components of the pump, such as a repair kit for parts of the system and the most recent recall for instructions and patient manuals.

Reasons for recalls range from electrostatic discharges causing pump failures in 2015, to unintended electrical disconnections between the power source and the controller of the pump in 2018, to the recall of numerous battery, data and adapter cables in April.

Certain recalls and issues predate Medtronic’s purchase of HeartWare in 2016; however, nine of the HVAD system’s 13 recall notices have come since the medtech giant’s acquisition.

The three Class I recalls in 2021 for Medtronic’s HeartWare HVAD system have resulted in a combined 91 injury and 15 death reports related to the issues, according to the FDA. 

Medtronic calculates a different total of reported deaths for the April recall. The company contends rather than the 12 deaths attributed to the issues by the FDA, one death was related to the issues, seven were potentially related and three were not related as of Jan. 7.

No death and injury reports data were provided in FDA recall notices for the system before 2020.

The question of why

The HeartWare HVAD system is a medical device that helps the heart pump blood for patients suffering from heart failure. The system, which includes an implantable pump and a non-implantable controller, is a Class III medical device, meaning it is high risk and can pose a significant risk of injury.

The device, and other ventricular assist devices, are typically used in patients critically ill or at risk of death. Similar products include Abbott Laboratories’ HeartMate II Left Ventricular Assist System and the company’s HeartMate 3.

While all three devices have had multiple recalls of system components, Medtronic’s HeartWare outpaces the other two systems, at least based on the publicly available data.

Data analyzed by watchdog group ECRI from the FDA’s recall database — which is separate from recall notices issued by the agency as the database lists recall of individual components or parts that can be involved in just one notice — shows that the HeartWare HVAD System has had 27 Class I recalls and eight Class II recalls between the system’s PMA approval of November 2012 and this April.

By comparison, Abbott Laboratories’ HeartMate II system had eight Class I recalls and three Class II recalls between the system’s PMA approval of April 2008 and April. And HeartMate 3 had one Class I recall and four Class II recalls between the system’s PMA approval of August 2017 and April.

Chris Lavanchy, engineering director for ECRI, said that it’s challenging to determine overall issues with a product by just looking at the number of recalls and that understanding why a recall or recalls are being made is crucial.

“[A recall] could be software changes that they’ve made, it could be things like the cables and mechanical things that are an issue. So, it’s really important to understand that whole history,” Lavanchy said.

Recalls are primarily voluntary and initiated by manufacturers. Reasons can also vary from devices shutting down to updates to instructions for use. However, Class I recalls are the FDA’s most serious label as continued use of devices can result in serious injuries or deaths.

Madris Kinard, CEO of Device Events, a company that compiles and interprets FDA medical device reports and recalls, said that numerous recalls for a list of different components of a device should trigger a review of the entire system, but the FDA may not always do this.

“These piecemeal recalls — when you do add them all together — is it a bigger problem with the entire device and not just each component part?” Kinard, a former FDA staffer, said.

If a device has multiple recalls in a short span of time, the FDA can work with manufacturers about further safety reviews, design changes or product labeling, according to a statement from the agency.

The FDA would not specifically comment on whether the agency is working with Medtronic on a full product review or any potential changes to the HeartWare system.

While the FDA has paused the marketing of products with a series of safety issues and initiated further safety reviews, a recent example being breast implant products, Kinard said that “it’s not something the FDA has done regularly.”

Reports of device malfunctions

Along with keeping track of recalls issued by manufacturers, the FDA also keeps a database of reports when patient injuries and deaths or device malfunctions occur. The Manufacturer and User Facility Device Experience (MAUDE) stores medical device reports made by mandatory reporters — manufacturers, importers and device user facilities — as well as voluntary reporters like healthcare workers, patients and consumers.

FDA acknowledges MAUDE’s limitations, noting the potential for incomplete or inaccurate reports, duplicative reports or under-reporting of events. Still, the database can offer a look into safety issues with specific devices and products.

An analysis of MAUDE by ECRI shows hundreds or thousands of injury and death reports have been made for the HeartWare HVAD system and Abbott’s competing products since each system’s PMA approval date. 

However, the HeartWare HVAD system has a higher rate of malfunction reports when compared to the total number of reports.

Since 2012, when the device received its PMA approval, device malfunction reports made up approximately 44% of the total reports. Malfunction reports made up 15% of total reports since HeartMate II’s PMA approval in 2008, and malfunctions made up 4% of reports since HeartMate 3’s PMA approval in 2017.

HeartWare HVAD’s rate of malfunction reports outpaces similar products
  HeartWare HVAD
HeartMate II LVAS
HeartMate 3
Deaths 3,390 2,698 337
Injuries 20,470 10,084 3,283
Malfunctions 18,530 (44%*) 2,312 (15%*) 134 (4%*)
Other 13 31 0
Total 42,403 15,125 3,754

SOURCE: Data compiled by ECRI from FDA’s Manufacturer and User Facility Device Experience database. The date range is from date of PMA decision to April 1, 2021.
*Shows what percentage of total reports are malfunction reports

When broken down by each year, the data shows that the percentage of malfunction reports has decreased since Medtronic acquired the HeartWare device in 2016 — the percentage of malfunction reports to total reports hit peaks of 74% in 2015 and 68% in 2017 but has dropped to 34% and 29% in 2020 and so far in 2021, respectively.

Mike Argentieri, ECRI’s vice president of technology and safety, said that the malfunction reports signal there may be larger issues with the device but the data itself is not enough to make that determination. 

ECRI would need to physically investigate products and speak with the manufacturer and hospitals that have flagged any issues to make a more definitive determination on device safety issues, according to Argentieri.

“It’s very hard to look at databases and come up with cause and effect, any database, even the recall [database,]” Argentieri said. “Signals cause you to look at something physically, in more detail, and that’s when you can get to actions being taken.”

Lavanchy said that no hospitals working with ECRI have flagged the Medtronic HeartWare device.