Medtronic has recalled some of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to a lack of energy being emitted from the devices.
The US Food and Drug Administration (FDA) identified this as a Class I recall, the most severe of device recalls.
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The recall was initiated by the medical device giant in May 2023 after receiving reports of 28 incidents and 22 injuries. The recall involves nearly 350,000 devices distributed over a five-and-a-half-year period from October 2017 to June 2023.
Medtronic’s ICDs and CRT-Ds are devices implanted in the heart to help monitor and regulate heart rhythm. When the heart goes into an irregular rhythm, the devices detect the out-of-sync heartbeat and produce an electric shock.
The ICDs and CRT-Ds, made after 2017 and built with a glassed feedthrough, may initiate an incorrect short circuit protection (SCP) feature – which leads to the delivery of low or no energy output when high voltage therapy is needed. The FDA said, in a recall alert, that the issue is more likely to occur in devices with a glassed feedthrough with a certain polarity.
The FDA tagged this as a Class I recall because a reduced-energy shock, or no energy shock at all, is dangerous if the arrhythmia is life-threatening. The failure to correct heart rhythm could lead to cardiac arrest. The agency also added that any surgeries needed to remove and replace the devices might present further harm.
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By GlobalDataMedtronic stated not to remove the devices in light of this fault, and to instead reverse the polarity of the voltage pathways. It also said to monitor patients as per normal clinical protocol.
Earlier this month, Medtronic had to cover off a cybersecurity flaw it identified in its cardiac device data platform. The company fixed the issue with a software update.
