Medtronic Defibrillator Recall Labeled Class I by FDA

Medtronic Defibrillator Recall Labeled Class I by FDA

Medtronic has found itself in the midst of yet another recall. In recent years, the medical device company has issued numerous recalls, many of which the FDA has labeled as Class I. From the company’s HVAD system implants to its MiniMed insulin pumps, individuals who have used Medtronic products have been plagued by a series of frightening recalls. The latest Medtronic defibrillator recall is no exception, as the FDA has warned that these defibrillators may cause serious injuries or death.  

About Medtronic’s Implantable Cardiac Devices  

Medtronic’s implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) monitor and regulate heart rate and rhythm for patients with various cardiac conditions. These implantable devices oversee the heart’s electrical activity, and when abnormal heart rhythms, known as arrhythmias, are detected, they automatically intervene to restore a normal heartbeat. In the event of arrhythmias, they deliver electric shocks. Furthermore, some of these devices offer an additional function known as cardiac resynchronization therapy (CRT), which is particularly beneficial for patients suffering from heart failure.  

These defibrillators’ quick actions can mean the difference between life and death for patients at risk of sudden cardiac arrest. However, the recent Medtronic defibrillator recall has raised concerns about potential issues with the devices’ Short Circuit Protection (SCP) feature.  

FDA Identifies Medtronic Defibrillator Recall as Class I  

The urgent recall of Medtronic’s ICDs and CRT-Ds is primarily due to a critical issue with the Short Circuit Protection (SCP) feature. Devices manufactured after 2017 with a glassed feedthrough are prone to reduced or no energy output during high-voltage therapy. The SCP feature protects the device from potential short circuits. But when the SCP kicks in at the wrong time, it blocks the necessary therapeutic shocks. Failure to administer the energy shock puts patients at risk for cardiac arrest, other serious injuries, or death.  

Medtronic has reported 28 incidents related to the malfunctioning SCP feature in the recalled ICDs and CRT-Ds. Among these incidents, 22 individuals have suffered injuries due to the failure of the devices to deliver adequate energy shocks. While, fortunately, there have been no reported fatalities so far, the potential consequences are grave. 

Recommended Actions Following Medtronic Defibrillator Recall  

The Medtronic defibrillator recall affected 348,616 products distributed between October 13, 2017, to June 9, 2023.  

On May 10, 2023, Medtronic sent an Urgent Medical Device Correction Notice to all customers. The letter contained Medtronic’s recommendations for healthcare providers and patients with the recalled defibrillators. Among these recommended actions, Medtronic advised not to replace the devices without reason. Additionally, healthcare providers should focus on reprogramming patients with a history of high-voltage therapy. For the full list of what patients and healthcare providers should do next, visit the FDA’s recall notice page 

The Lake Law Firm will continue to monitor the Medtronic defibrillator recall and potential injuries that may have been caused as a result of these faulty devices.