Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

The U.S. Food and Drug Administration (FDA) has issued a release stating that Medtronic is recalling the HVAD Pump Implant Kit due to a pump weld defect.

June 8, 2022 — The U.S. Food and Drug Administration (FDA) has issued a release stating that Medtronic is recalling the HVAD Pump Implant Kit due to a pump weld defect. Following an inspection of explanted pumps returned to Medtronic, an analysis showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly.

This issue can lead to pump malfunction, death, or severe injury (for example: shock with severe organ dysfunction, stroke), or require patients to undergo major surgery to replace the pump.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

Product Name: HVAD Pump Implant Kit
Models: 1101, 1103, 1104, 1104JP, MCS1705PU
Distribution Dates: October 11, 2006 to June 3, 2021
Devices Recalled in the U.S.: 1,614
Date Initiated by Firm: April 11, 2022

Device Use

The HeartWare Ventricular Assist Device (HVAD) System is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned.

Reason for Recall

Medtronic is recalling the HVAD Pump Implant Kit due to a pump weld defect. Following an inspection of explanted pumps returned to Medtronic, an analysis showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly. Patients with affected devices may present with signs and symptoms that resemble pump thrombosis.

If this issue occurs, it may lead to pump malfunction, death, or severe injury (for example: shock with severe organ dysfunction, stroke), or require patients to undergo major surgery to replace the pump.

Medtronic has received three complaints regarding this device issue, including one death, and two injuries.

Who May be Affected

Health care providers using the Heartware HVAD System
Patients who have procedures with the Heartware HVAD System

What to Do

On April 11 2022, Medtronic sent an Urgent Medical Device Correction letter to select physicians and health care providers who have unused HVAD Pump Implant Kits to request that the product be returned.

On April 26, 2022, Medtronic sent an Urgent Medical Device Correction letter to all physicians and health care providers to inform them of this potential pump weld defect.

The letter requested customers to:

Upload and submit all .csv logfiles to Medtronic when patients present with the signs and symptoms listed in the letter.
Consider whether patients presenting with any of the signs and symptoms listed in the letter could be caused by a pump thrombus and treat accordingly. Physicians should make decisions about removing or exchanging the pump on a case-by-case basis, considering the patient's clinical condition and surgical risks.
Share the letter with all those who need to be aware within their organization or any organization where potentially affected patients have been transferred.
Complete the enclosed Customer Confirmation Form and email to [email protected].