Breaking News: Medtronic’s Class I Recall For Implantable Cardiac Devices “Can Lead to Cardiac Arrest, Other Serious Injury, or Death”

by Robert Wilson | Last updated Jul-19-23

Breaking News: Medtronic’s Class I Recall for Implantable Cardiac Devices “Can Lead to Cardiac Arrest, Other Serious Injury, or Death”

Front building Medtronic

Medtronic is in the news again. 

This time because the U.S. Food & Drug Administration (FDA) Announced a Class I recall for two of the company’s implantable cardiac devices. This means the complications associated could cause serious injury or death. 

The implications of this recall are alarming, especially given the recent slate of medical device recalls associated with the company since last year. This particular recall, along with its others, could raise serious concerns about the safety and reliability of Medtronic’s medical devices and the potential risks to patients. 

History of Medtronic’s Recent Recall

Medtronic originally issued an Urgent Medical Device Correction Notice to patient-customers on May 10, 2023 for these affected devices. The Notice encompassed its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured between October 13, 2017 to June 9, 2023 due to a potential for reduced-energy or no-energy high-voltage therapy.  

The issue is caused by an unintended current pathway that may trigger the Short Circuit Protection (SCP) feature, leading to a reduced-energy shock or no shock at all and may fail to correct a life-threatening arrhythmia, potentially leading to cardiac arrest, serious injury, or death. 

What Are Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)?

Implantable defibrillators that are used to detect and treat life-threatening irregular heartbeats carry additional risks when defective, including surgical intervention.

Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are small devices that are surgically implanted in the body to monitor and regulate heart rhythm. 

ICDs are designed to detect and treat life-threatening arrhythmias by delivering electric shocks, restoring a normal heartbeat and preventing sudden cardiac arrest. On the other hand, CRT-Ds are used for patients with heart failure and abnormal heart conduction. 

In general, they help coordinate the contractions of the heart’s chambers, improving pumping efficiency and reducing heart failure symptoms like fatigue and shortness of breath.

How Can Patients Identify The Recalled Devices?

The devices mentioned in this recall can be identified by checking their serial number look-up at http://productperformance.medtronic.com. 

These devices were manufactured with a specific (glassed) feedthrough and fall under the brand names: 

• Cobalt XT, Cobalt, Crome ICDs and CRT-Ds
• Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds
• Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs

What is a Class I Recall And When Are They Issued?

Food and Drug Administration (FDA) classifies medical device recalls based on the severity of the potential hazard posed by the product being recalled. A Class I recall is the most serious type of recall and is reserved for products that have a reasonable probability of causing serious adverse health consequences or death.

According to the FDA, a Class I recall may be issued when a device presents a serious risk to patient health, such as a defect that could cause the device to malfunction or fail. The FDA takes Class I recalls very seriously and expects companies to take immediate action to address the problem and protect patient safety.

The Numbers: Devices Affected and Injuries Reported

Medtronic has reported 28 occurrences, 22 injuries, and no deaths out of 348,616 devices revealed in the FDA’s Class I recall in the United States.

Out of 348,616 devices announced in FDA’s Class I recall in the United States, Medtronic has reported 28 incidents, 22 injuries, and no deaths. Prophylactic device replacement is not recommended, and Medtronic is providing comprehensive patient management recommendations to physicians.

Is Medtronic’s Product Acquisition Strategy A Source Of Their Alarming Pattern of Device Recalls?

The FDA blasted Medtronic with 11 Class I recalls in 2022 and 12 in 2021. The number of Class I recalls outpaces most, if not all, other medical device manufacturers. Many recalls are from products manufactured from companies they have acquired. However, that does not discharge them from ensuring the implementation of safety measures.

In light of this recall, Medtronic has been grappling with a distressing rise in serious medical device recalls. This is the second medical device recall this year for the company. In January, the FDA announced another Class I recall for over 22,000 catheters due to a defect.

But that is just the tip of the iceberg. In 2022, the FDA hammered Medtronic with a whopping 11 Class I recalls in 2022 and 12 in 2021. 

Further review of the company’s growth could give insight into this dangerous pattern. The company’s heavy reliance on acquired products could be a source of concern. Is the company pursuing rigorousness safety assessments? This alarming trend of recalls highlights another critical question: Should the pursuit of cutting-edge technologies come at the cost of potential risks to patients’ lives? Medtronic’s challenges serve as a stark reminder that safety should never be compromised, even in the face of potential mounting pressure for progress.

As we navigate the intricate landscape of medical advancements, it becomes imperative for all stakeholders—the industry, regulatory bodies, and healthcare providers—to come together and prioritize patient safety above all else. By fostering a culture of unwavering commitment to quality and stringent safety assessments, we can ensure that the next breakthrough in medical devices brings hope and healing, rather than contributing to a distressing surge in recalls.