On July 18, 2023 Medtronic recalled approximately 384,000 ICD and CRT-D devices due to increased potential for a reduced- or no-energy HV therapy.
The devices, manufactured after July 17 have a glassed feedthrough, and its insulating layers may separate. When this happens, an unintended current pathway forms within the void created by the insulation separation, capable of conducting high levels of current during HV therapy. The low-energy output issue is most likely to appear when the device is programmed to deliver therapy in the AX>B pathway.
According to the notification distributed by HRS in May of 2023:
“This behavior can be intermittent; both full-energy and reduced-energy HV therapies within the same episode have been observed. SCP events may also be lead-related; for both lead-related and device-related unintended current pathways, the defibrillation waveform is truncated early in the energy delivery sequence, resulting in reduced or no energy being delivered (~0-12J) – so that it may be difficult to distinguish between the two mechanisms.”
The products listed in the recall include the Cobalt and Cobalt XT, Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva, and Brava CRT-Ds; and the Visia AF and Visia AF MRI, Evera, Evera MRI, Primo MRI, and Mirro MRI ICDs.