Class I Recall: Medtronic Pump Implant Kits Delayed or Failed to Restart After the Pump was Stopped

A Class I recall, the most serious type of recall, has been issued for Medtronic HVAD Pump Implant Kits.

“Use of these devices may cause serious injuries or death,” the FDA announcement stated. 

Since medical devices are implanted in a patient’s body, defective products can lead to very serious complications. 

For instance, in the case of hernia mesh implants, many patients who had their hernias repaired with the hernia mesh have reported a wide array of side effects which includes autoimmune diseases, neurological problems, and fistulas, just to mention a few.

The adverse events reported along with the poor performance of the product have led to some hernia mesh implant recalls, and individuals who have experienced complications have also started filing Hernia Mesh lawsuits, which still see a growing number of plaintiffs as of date. 

In the case of Medtronic, this is the latest recall the company has issued on the HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit which is part of the HeartWare HVAD System. 

According to the FDA announcement published on March 1, Medtronic is recalling the device because of possible failures in starting, restarting, or delay in restarting after the pump was stopped.

What Is The HVAD Pump Implant Kit Used For?

The HVAD Pump Implant Kit is used by patients who suffer from severe heart disease, especially those in need of a transplant but haven’t found a donor yet. 

The kits are mainly used to help these patients by helping the heart to continue pumping blood to the rest of the body. 

Other individuals who usually seek help from these devices are those who are undergoing heart tissue recovery, and those who are at risk of death from end-stage left ventricular heart failure. 

Why Was The Device Under A High-Priority Recall?

A high-priority recall was issued for the HVAD Pump Implant Kits because the device may fail to initially start, restart, or experience a delay in restarting after the pump was stopped, according to the FDA announcement. 

These delays or failures to start or restart took place during preimplant testing, during the implant, or in a wide array of post-implant situations. 

When these issues occur, the pump will not react as intended to restart the heart, causing serious harm to patients such as a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death. 

Affected Lots

The Class I recall covers three lots of HVAD Pump Implant Kits with model numbers PUMP 1103, PUMP 1104, and PUMP 1104JP. 

The product recall covers 506 pumps worldwide, including 157 in the United States. 

According to the FDA announcement, distribution dates were from October 23, 2017 to April 30, 2020. 

What You Can Do

To date, there have been 29 complaints associated with the use of the device, including 19 serious incidents, 8 cases of patients who had a life-threatening experience but managed to recover without long-term effects, and 2 reported deaths. 

In December 2020, Medtronic notified all affected customers through an Urgent Medical Device Communication letter, along with the instructions on next steps they have to take if they have previously purchased a Medtronic HVAD Pump.

Are you a health care provider using the affected HVAD Pump Implant Kits?

Or maybe a patient who recently had or is set to have procedures with the affected device?

If so, you may report adverse reactions or problems linked to the use of these devices to the FDA’s Adverse Event Reporting program.