Safety Alerts and Notifications

January 21, 2021

Medical Device Notice: Updated notice for Heartware HVAD systems ref#1103

In December 2020 Medtronic International Ltd has issued a notice regarding Medtronic Heartware TM Ventricular Assist Device (HVAD).  Medtronic has identified an issue with implanted HVADS's where the pump may experience a delay to restart or failure to restart. Pumps at a greater risk of failure are due to an internal component specific to (3) lot numbers. The issue only occurs in pumps that are stopped after the initial startup phase. Please refer to the following link for Medtronic's notice and patient management recommendations. Be advised:  This issue does not impact the performance of a pump while it is running.  

https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/heartware-hvad-medical-device-correction-december-2020.pdf

October 15, 2020

Safety Notice - FDA Alert

On September 30th, 2020, the U.S. Food and Drug Administration posted a letter to health care providers regarding reports of nontuberculous mycobacteria (NTM) infections in patients who had undergone cardiothoracic surgery involving the use of CardioQuip Modular Cooler-Heaters. 

The letter can be found at the following link: 

https://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-infection-during-cardiac-surgery-when-using-cardioquip-modular-cooler-heater-device

While the root cause of infection in these cases is not yet known and continues to be evaluated, the FDA provides general recommendations to reduce the risk of infection during cardiac surgery when using any heater-cooler device.  We will update the community in the event that more information becomes available.

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