USA — In a move of utmost importance, Medtronic, a leading medical technology company, has initiated a recall of nearly 350,000 implantable cardiac devices due to concerns related to the delivery of high-voltage energy.
The announcement from the US Food and Drug Administration (FDA) categorizes this recall as Class I, indicating its gravity as the most severe type.
According to the FDA, the problem lies in the potential delivery of “reduced-energy shock, or no shock at all,” which could fail to correct life-threatening arrhythmias, leading to cardiac arrest, severe injury, or even death.
Additionally, patients with affected devices may face further risks if they require surgical procedures to remove and replace faulty implants.
The recall impacts selected implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) that were distributed between October 2017 and June 2023.
The affected products include models like Cobalt, Chrome, Claria, Amplia, Compia, Viva, Brava, Visia, Evera, Primo, and Mirro.
These devices, which contain a glass feedthrough component, are susceptible to delivering low or no energy when needed, due to the inappropriate activation of the short circuit protection feature, as reported by the agency.
Notably, this is not the first time that Medtronic has faced such an issue; in the previous year, the company recalled more than 87,000 devices for a similar problem with energy delivery.
Although there have been 28 incidents and 22 injuries reported thus far, there have been no reported fatalities linked to the issue. However, it is essential to address the problem promptly to ensure patient safety.
Medtronic took the initiative to initiate the recall on May 10, 2023, while also advising physicians against replacing already implanted devices.
Instead, they issued device programming instructions to minimize the risk and recommended remote monitoring of patients using normal protocols.
Healthcare professionals and consumers have been urged to report any adverse events or device-related problems through the FDA’s MedWatch Safety Information and Adverse Event Reporting System.
To mitigate the potential risks, Medtronic has advised healthcare providers to reprogram the devices, altering certain configurations, while also advising against prophylactically removing the implants.
It is important to note that this is not the first instance of Medtronic facing recalls related to their ICDs.
The company previously recalled over 20,000 ICDs in the US due to a similar issue with the delivery of shock energy during high-voltage therapy.
Furthermore, two years ago, they recalled 240,000 defibrillators due to concerns regarding a rapid decrease in battery life.
Medtronic has been proactive in addressing these concerns, aiming to improve the safety of its products.
The issue was identified by Medtronic as part of routine product analysis, highlighting the importance of regular evaluations.
In a separate incident, earlier this month, Medtronic addressed a cybersecurity flaw in its cardiac device data platform, promptly resolving the issue through a software update.
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