The Proclaim and Infinity IPGs were recalled due to their inability to exit magnetic resonance imaging (MRI) mode as they may lose the ability to connect or communicate with their IPG in that mode
Abbott Medical’s recall of Proclaim and Infinity implantable pulse generators (IPGs) has been classified by the US Food and Drug Administration (FDA) as Class 1, which indicates the most severe kind of recall.
According to the US health regulator, the use of these devices can cause serious injuries or death.
The Proclaim and Infinity IPGs were recalled due to their inability to exit magnetic resonance imaging (MRI) mode.
The list of affected devices includes Proclaim XR 5 IPG Model 3660, Proclaim XR 7 IPG Model 3662, Proclaim Plus 5 IPG Model 3670, Proclaim Plus 7 IPG Model 3672, Proclaim DRG IPG Model 3664, Infinity 5 IPG Model 6660 and Infinity 7 IPG Model 6662.
Abbott will recall 155,028 devices distributed between 21 November 2015 and 29 June 2023.
FDA said that the people receiving neurostimulation from the Proclaim XR SCS System, Proclaim Plus SCS System, Proclaim DRG Neurostimulation System or Infinity DBS System are at potential risk.
The flawed IPGs like the Proclaim XR SCS System, Proclaim Plus SCS System, Proclaim DRG Neurostimulation System and Infinity DBS Systems, can also affect healthcare personnel providing care, including but not limited to referring physicians who monitor patients regularly.
The Abbott Proclaim neurostimulation systems provide electrical impulses of low intensity to neural areas. The Proclaim XR and Proclaim Plus implantable pulse generators (IPGs) are used for Spinal Cord Stimulation (SCS).
These devices are said to offer the option to stop delivering therapy when a patient completes receiving the MRI.
Bluetooth technology is used to link the Patient Controller (PC) device, an iPhone or iPod with a PC application (app), to the patient’s IPG. The patient’s IPG is put into MRI mode using the PC device, which stops the delivery of therapy, FDA added.
Abbott is recalling its Proclaim and Infinity IPGs as the PC device may lose the ability to connect or communicate with its IPG while in MRI mode. Its use may need surgery to remove the device and replace it with a new device.
According to the American health regulator, there have been 186 reported incidents and 73 reported injuries without any death reports.
In July, the medical device firm issued an Urgent Medical Device Correction letter and recommended steps to reduce the risk of loss of therapy and the need for IPG replacement surgery.