Medtronic, the world’s largest medical device manufacturer, is currently grappling with yet another recall. In the last few years, the company has issued a series of recalls, a substantial portion of which the FDA has classified as Class I recalls. The most recent Medtronic recall concerns the company’s implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), which, like many Medtronic recalls before, has been labeled a Class I recall by the FDA due to the risk of serious injuries or fatalities linked to these devices.
Medtronic Struggles to Escape Class I Recall Streak
Medtronic’s portfolio includes a range of medical devices, such as insulin pumps, cardiovascular products, hernia mesh implants, spinal and orthopedic systems, and more. While the company’s prolific manufacturing track record is impressive, it has racked up a disturbing list of Class I recalls, with 12 occurring in 2021 and another 11 in 2022.
Only halfway into 2023, the medical device giant has found itself the subject of another Class I recall, this time for its implantable cardiac devices.
Medtronic’s implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) serve patients grappling with diverse cardiac conditions. The ICD and CRT-D play a pivotal role in monitoring and regulating heart rate and rhythm, overseeing the intricate electrical activity of the heart. When they detect abnormal heart rhythms, known as arrhythmias, these devices automatically intervene to restore a healthy heartbeat. In these cases, the defibrillators administer electric shocks to restore normal heart function. Notably, some models also offer cardiac resynchronization therapy (CRT), a feature to assist patients struggling with heart failure.
FDA Elevates Medtronic Defibrillator Recall to Class I
The urgency surrounding the Medtronic defibrillator recall stems from a critical issue involving the Short Circuit Protection (SCP) feature. Devices manufactured after 2017, equipped with a glassed feedthrough, are susceptible to outputting reduced or nonexistent energy during high-voltage therapy. The SCP feature safeguards the device against potential short circuits. However, when the SCP activates at the wrong time, it obstructs the necessary therapeutic shocks. The failure to deliver the required energy shock places patients in jeopardy of cardiac arrest, severe injuries, or even death.
Medtronic has reported a concerning tally of 28 incidents connected to the malfunctioning SCP feature in the recalled ICDs and CRT-Ds. Among these incidents, 22 individuals have suffered injuries due to the devices’ inability to administer adequate energy shocks. However, the company has not received any reports of fatalities.
Recommended Course of Action Outlined by Medtronic
The Medtronic defibrillator recall affects 348,616 units distributed between October 13, 2017, and June 9, 2023.
On May 10, 2023, Medtronic dispatched an Urgent Medical Device Correction Notice to healthcare providers. This notice provided healthcare providers and patients with crucial guidance on managing the recalled defibrillators, such as advising patients against preventatively replacing devices and encouraging healthcare providers to reprogram patients who previously received high-voltage therapy.
Whether the ensuing complications from these recalled defibrillators will spawn additional lawsuits against Medtronic remains to be seen. The company is already battling litigation surrounding its MiniMed insulin pumps and HeartWare Ventricular Assist Device (HVAD).