Medical Device Network

FDA label Abbott Medical recall as Class I

Abbott Medical recall Proclaim systems and Infinity IPGs following reports of patients unable to exit MRI mode.

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.

The devices at the centre of the recall are designed to deliver low-intensity electrical impulses to nerve structures. The products affected include the Proclaim XR and Proclaim Plus implantable pulse generators (IPGs), used for Spinal Cord Stimulation (SCS). The Proclaim DRG IPG, used for Dorsal Root Ganglion (DRG) stimulation and the Infinity IPGs, used for Deep Brain Stimulation (DBS).

They work with a Patient Controller (PC) device using an app on an iPhone or iPod which connects to the IPG through Bluetooth. It has the option to disable the delivery of therapy when a patient receives an MRI but there have been reports of users unable to exit the MRI mode as PC’s are unable to connect or communicate with the IPG while in MRI mode. This occurred following an update of iOS systems on apple products.

Those with affected IPGs will need to replace it with a new device and may require surgery.

Abbott Medical issued an Urgent Medical Device correction letter on the 18th of July to all the affected implanting surgeons. The letter recommends patients not to delete the paired Bluetooth connection between their IPG and PC. It also advises patients to update the PC app before entering the MRI mode with the “Patient Controller NR - US” application from the Apple App Store.

Abbott’s recent Class I recall is just the latest in a long list of device issues this year. Just this month, the FDA tagged Mallinckrodt’s one-way valve recall as Class I and handed Getinge’s Cardiosave Hybrid and Rescue Intra-aortic balloon pumps the same certification after several issues emerged about the troubled device.