May 8, 2024

The FDA Identifies Medtronic Recall As Class I After 22 Injuries

The FDA Identifies Medtronic Recall As Class I After 22 Injuries - heart rate

What: The Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough.

Who: Medtronic.

When: May 10, 2023.

Why: The items have been recalled due to continued issues with their ability to deliver high voltage therapy when necessary, which can lead to cardiac arrest, other serious injury, or death.

Where: Medtronic has issued the recall for the devices sold in the United States. 

How Can I Identify The Recalled Product?: Individuals who have had the devices implanted or who have worked with the recalled cardiac devices can head to the FDA’s “Medical Device Recall Database” entries to find the product codes. 

 

On May 10, 2023, Medtronic, an American medical device company, recalled nearly 350,000 implantable cardiac devices due to continued issues with their ability to deliver high-voltage therapy when necessary. According to the advisory posted on the U.S. Food and Drug Administration (FDA) website, the issues with the cardiac devices can lead to “cardiac arrest, other serious injury, or death.” The FDA has categorized this as a Class I recall, and it includes all implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a glassed feedthrough manufactured after 2017.

 

Why Are the Medtronic Cardiac Devices Recalled?

According to the notice posted on the FDA’s website, the medical company Medtronic is recalling all ICDs and CRT-Ds, manufactured after 2017 with a glassed feedthrough, as “they may deliver low or no energy output when high voltage therapy is needed due to inappropriate activation of the Short Circuit Protection (SCP) feature.”

The report states that the issues may more likely occur for the devices with a glassed feedthrough that are configured to deliver therapy in the “AX>B delivered pathway.” If these devices fail to produce the necessary energy shock or any shock at all, it could fail in correcting a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or death. 

Why Did the FDA Label This as a “Class I” Recall?

The FDA classifies recalls into a numerical designation: I, II, or III. Depending on the degree of health hazard presented by the product being recalled, it will be classified as the following:

  • Class I: There is a reasonable probability that the use of, or exposure to, a violative product will cause seriously harmful health consequences or can lead to death.
  • Class II: The use of, or exposure to, a violative product may cause temporary or medically reversible harmful health consequences or if the probability of serious health consequences is likely.
  • Class III: The use of, or exposure to, a violative product is not likely to cause negative health consequences.

Due to continued issues with their ability to deliver high voltage therapy when necessary, which can lead to cardiac arrest, other serious injury, or death, the Medtronic implantable cardiac devices recall has been classified as a Class I recall by the FDA.


Which Medtronic Products are Involved in the Recall?

The Specific Medtronic implantable cardiac devices included in the recall include the following:

  • 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

 

Who May Be Affected by This Recall?

Those individuals who have the impacted ICDs and CRT-Ds, and the Health care providers who implant and manage patients with ICDs and CRT-Ds are affected by this recall. To learn more about this case and if you may be affected by the Medtronic recall, contact a Morgan & Morgan attorney today. 

 

Have There Been Injuries Reported?

According to the report posted on the FDA’s website, due to the ongoing issue, there have been 28 incidents, 22 injuries, and no reported deaths. However, if you believe you have been affected or injured by one of the recalled implantable cardiac devices, we may be able to help you. For more information, contact a Morgan & Morgan attorney today. 

 

Who Is Liable for My Injuries?

When it comes to the Medtronic implantable cardiac devices recall, there are many factors that come into play when it comes to who is liable for your injuries. If you have been injured by one of the implantable cardiac devices, speaking to an experienced attorney like the ones at Morgan & Morgan can help you better understand who may be directly responsible for any damages you or your loved ones have suffered. In some cases, multiple parties may be liable. At Morgan & Morgan, we believe it is vital to hold all parties responsible in order to ensure you have the best chance are getting the full and fair amount of compensation you deserve for your injuries.

For more information on how we may be able to help, contact us today

 

What Remedies Is Medtronic Providing?

On May 10, 2023, the medical company Medtronic issued an Urgent Medical Device Correction Notice to its affected customers. The notice asked that their customers take the following actions in relation to the software issue related to this recall: 

  • Medical providers are to program all high voltage therapy pathways B>AX in all therapy zones to minimize the risk of this issue.
  • Medical providers are to prioritize reprogramming patients with a history of high-voltage therapy and Rx1 programmed AX>B.
  • Medical providers are to encourage patients with AX>B programming in any high-voltage therapy sequence to attend their next scheduled follow-up in clinic for device reprogramming.
  • Medical providers are to monitor patients remotely following standard clinical protocol.

Customers are urged to contact the medical company via its Technical Services hotline (1-800-929-4043) if they have observed or if there is any indication that either:

  • Reduced- or no-energy high voltage therapy is displayed in Episode Text  or
  • There is a persistent drop of approximately 50% in RA, RV, and LV pacing lead impedance measurements.

For more information regarding the recall, or to learn more about what remedies are being provided to those affected by the cardiac devices, we urge you to connect with our attorneys today. 

 

How Can a Morgan & Morgan Attorney Help?

Working with an experienced attorney can help boost your chances of recovering the compensation you and your loved ones deserve after you’ve been injured by the recalled Medtronic implantable cardiac devices. At Morgan & Morgan, our attorneys have over 35 years of experience, making them uniquely qualified to handle your case. To learn more about how one of our attorneys can help you, please complete our free, no-obligation case evaluation form today. See why millions trust Morgan & Morgan. 

 

Should I Contact a Morgan & Morgan Attorney?

Speaking with a Morgan & Morgan attorney will always help benefit your case. At Morgan & Morgan, we have over 35 years of experience helping victims like you get the justice you deserve when companies allow dangerous products into the consumer market. If you or a loved one have suffered an injury or death after you’ve had one of the affected ICDs and CRT-Ds implanted, we may be able to help you. 

For more information behind this recall or to learn more about how we can help your case, contact a Morgan & Morgan attorney today by completing our free, no-obligation case evaluation form today.