The U.S. Food and Drug Administration (FDA) has issued a recall for Medtronic’s HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit after they were found to have dangerous defects. The June 8 Class I recall is, according to the FDA, “the most serious type of recall” with the use of Medtronic’s HVAD kits potentially causing serious injuries or death.
Medtronic’s HVAD Pump Implant Kit is a type of medical device that is used to help the heart pump blood for a patient who has difficulty doing so on their own. HVAD Systems are used to help cardiac transplant patients who are at risk for complications such as left ventricular failure, patients receiving heart tissue recovery, or as a form of destination therapy for patients who are not planning on receiving a heart transplant.
Medtronic recalled the HVAD Pump Implant Kits because of a pump weld defect. This defect allows moisture to enter the central post of the HVAD pump. Once moisture enters this area, corrosion and demagnetization of the internal magnets of the units can occur. This damage can cause the device’s pump to rotate incorrectly. The defect was discovered after a number of HVAD pumps were removed and sent back to Medtronic for analysis.
According to the FDA, if the HVAD pump kit malfunctions in this way, the patient may suffer from:
- Pump malfunction
- Severe injury
- Severe organ dysfunction
In some instances, these defects can cause pump thrombosis, a medical situation in which the flow of blood is blocked by the device, which can lead to further medical complications. In addition, patients may be required to undergo major surgery to replace the pump. According to the FDA, Medtronic has received a number of complaints about the HVAD kit including one death.
The FDA recall states that the Medtronic HVAD Pump Implant Kits recalled are models 1101, 1103, 1104, 1104JP, and MCS1705PU distributed between October 11, 2006, and June 3, 2021. According to the agency, this recall affects 1,614 consumers.
In addition to expressing the dangers posed by the HVAD pump implant kits, the FDA also explained the actions taken by Medtronic to address the dangers of their product. According to the FDA, on April 11, Medtronic sent an Urgent Medical Device Correction letter to physicians and health care providers with unused HVAD pump implant kits requesting that they be returned. Then, on April 26, Medtronic expanded the Medical Device Correction letters to all physicians and healthcare providers in order to apprise them of the weld defect.