Medtronic recently issued a recall for its nearly 350,000 implantable cardioverter defibrillator (ICD) devices, which include product lines such as Cobalt, Evera and Visia. These products are their most prominent devices and, in the past, have established Medtronic as the market leader, accounting for an estimated 40% of the ICD market. Against this backdrop, the product recalls threaten the company’s position in the ICD market, which was worth $2.84 billion in 2022 and expected to reach $3.84 billion in 2033, says GlobalData, a leading data and analytics company.

Abbott is the second largest player making up approximately 28% of the market in 2022, according to GlobalData’s market models, and 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 be attributed to this recall as well.

Aidan Robertson, Medical Analyst at GlobalData, comments: “The recent recalls are sure to have a negative impact on Medtronic’s presence in ICD and could pave the way for competitors such as Abbott and Boston Scientific to take the lead in the foreseeable future. Once there are functional issues with any class 3 medical device, it can be difficult to regain confidence in that company’s products going forward.”

ICDs are implanted in the heart to monitor and regulate heart rhythms, and when the device detects an irregular heart rhythm, it delivers an electric shock. Current complications are with Medtronic’s products created after 2017, which contain glassed feedthrough that may initiate incorrect short circuit protection. This results in a low or no energy output when 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, removal of the devices can cause more harm and thus reversing the polarity of the voltage pathways has been recommended instead.

Robertson continues: “While it is unlikely that these events will result in the complete replacement of Medtronic’s position in the market, we can expect this to notably decrease their ICD market value.”