The issue described in this recall notice is the same one that was announced in the Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers on April 28, 2022.
The 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.
- 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
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 RS.CFQFCA@medtronic.com.
Health care providers with questions about this recall should contact their local Medtronic Representative.
Patients with questions about this recall should contact Medtronic Patient Services at 800-635-3930 (Monday-Friday, 8 a.m. to 5 p.m. Central time).
- Medical Device Recall Database Entry
- Potential for Internal Pump Malfunction in the Medtronic HVAD System - Letter to Health Care Providers
- Medtronic Urgent Medical Device Correction
- Medtronic HeartWare Ventricular Assist Device (HVAD) System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.