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FDA label Abbott Medical recall as Class I

September 14, 2023

Abbott Medical is recalling its Proclaim neurostimulation systems and Infinity IPGs after receiving complaints that users were unable the exit the magnetic resonance imaging (MRI) mode.

On 13 September, the US Food and Drug Administration (FDA) identified it as a Class I recall meaning it has a risk of causing serious injury or death.

There have been 186 reported incidents of faulty devices and 76 cases of injuries. So far, no deaths have been reported.

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