Implantable cardioverter defibrillators (ICDs) are implanted in the heart to monitor and regulate heart rhythms.

When an ICD detects an irregular heart rhythm, it delivers an electric shock.

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Medtronic is currently facing complications with products that were manufactured after 2017 and contain glassed feedthrough, which may initiate incorrect short circuit protection that results in low energy or no energy output in situations where high voltages are required. Failure to correct these irregular heart rhythms may lead to cardiac arrest.

The recall was first started in May 2023 when 28 incidents and 22 injuries were reported due to device malfunctions. Even though a recall was initiated, the removal of the devices can also cause harm. As such, a reversal of the polarity of the voltage pathways has been recommended instead.

Medtronic’s position in ICD market is no longer secure

Medtronic’s position in the ICD market is no longer secure after its recall of nearly 350,000 devices, including products such as the Cobalt, Evera, and Visia. These products are the company’s most prominent devices and, in the past, have established Medtronic as the market leader. Together, they accounted for an estimated $2.82bn in 2022, or 40% of the ICD market, and are expected to reach $3.84bn in 2033 according to GlobalData, a leading data and analytics company.

The recent recalls are sure to have a negative impact on Medtronic’s presence in the ICD market, and could give a way for competitors such as Abbott and Boston Scientific to take the lead for the foreseeable future. Once there are functional issues with any class 3 medical device, it can be difficult for consumers to regain confidence in that company’s products going forward.

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Abbott is the second largest player in this space, making up an estimated 28% of the market in 2022. It has been making significant gains during Q2 2023 with its most prominent product, Gallant. Boston Scientific had an estimated 15% market share in 2022 and has had similar increases in its products’ success throughout Q2 2023 that may also be attributed to this recall. While it is unlikely that these events will result in the complete replacement of Medtronic’s position in the market, it is expected to notably decrease the company’s ICD market value.