A Class I recall is the most severe type of recall by the Food and Drug Administration (FDA). It only happens when a product’s use or exposure can lead to severe deaths or injuries.
Here is why the FDA issued a Class I recall on HeartMate II and HeartMate 3.
Heartmate II and Heartmate 3
For the elderly who are sick and cannot get a transplant, these two pumps provide a solution to extend life. The mechanical pump offers hope for patients whose hearts cannot pump blood independently. But are these pumps safe?
Following more than 130 reports amounting to 14 deaths and numerous injuries related to this pump, the FDA issued a recall notice in June 2024. Notably, this is not the only recall facing this pump. Abbott has often issued “correctional letters” to indicate new pump issues.
In January of this year, for example, Abbott claimed that HeartMate 3 had the potential to start and stop because of a fault in the communication system. This is a defect present in pumps already on the market.
Despite the negative reports, Abbott Laboratories denies any correlation between their pumps and the resulting deaths and injuries.
“The complexity of the device – combined with patients battling late-stage heart failure and associated comorbidities – creates very dynamic clinical care situations,” says Justin Paquette, a public affairs director at the company.
FDA Reports Show Direct Complications
Reports from as early as 2020 show that over time, these two pumps caused an accumulation of “biological materials,” leading to obstruction after continuous usage. As with other reports, Abbot issued a correctional letter. This time, they claimed they were working on a solution to this design problem.
While physicians have long been advised to share the potential side effects of blockage, the FDA continues to receive reports affirming consistent obstructions among patients who use the pumps.
So, despite the blockages,
Why Are Physicians Still Recommending the Pump?
Last Resort
For most patients with end-stage heart failure, there is no option for long-term therapy. HeartMate II or HeartMate 3 promises an extended period of life. Cardiologists are facing a challenge in breaking the news that there is no alternative solution for their patients.
Reporting Is Complicated
On the other hand, physicians are not obligated to report adverse effects of the products they prescribe as the mandate falls squarely on the manufacturer and hospital. Furthermore, submitting a report to FDA is often not an admission that a product is causing death. A report can be inaccurate, misinformed, or invalidated by lack of proper reference.
Will the Pumps Be Removed From the Market?
Understanding the critical role that they play, physicians have since called for accurate reports from Abbott. However, it is still unclear whether these products will be removed from the market as that is not happening now.
If it does happen, the consequences for victims would be dire since these pumps are often the last resort for patients with end-stage heart failure. While many physicians will agree that these devices are not perfect, they are still better than they were several years ago, when the technology was still novel.
What’s more, it’s currently unclear how many of these devices are in use all over the world, as this is proprietary information.
Conclusion
“Each year, thousands of injuries and fatalities in the U.S. are caused by dangerous and defective household and industrial products. If you or a loved one have suffered due to a faulty product, we are here to advocate for you,” says attorney Arthur Schechter of Schechter, Shaffer & Harris, LLP – Accident & Injury Attorneys.
