CanadaAbbott Medical's Infinity DBS, Proclaim SCS and Proclaim DRG implantable pulse generators are affected; model/catalog numbers include 6660, 6661, 6662, 6663 and 3660, 3661, 3662, 3663, 3664, 3665, 3667 (more than 100 lot/serial numbers affected—contact manufacturer for specific numbers). The notice reminds health care providers these systems contain a Surgery Mode feature intended to help protect the implanted device from potential interference associated with the use of electrosurgical units during certain surgical procedures; contact the manufacturer for additional information.
What's being recalled
Companies: Abbott Medical, 6901 Preston Road, Plano, Texas, United States, 75024.
How to identify it
Affected products: Infinity™ 5 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 6660
Affected products: Infinity™ 5 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 6661
Affected products: Proclaim™ XR 5 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 3660
Affected products: Proclaim™ XR 7 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 3662
Affected products: Proclaim™ 5 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 3665
Affected products: Proclaim™ 5 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 3661
Affected products: Proclaim™ 7 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 3667
Affected products: Proclaim™ 7 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 3663
Affected products: Proclaim™ DRG Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 3664
Affected products: Infinity™ 7 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 6663
Affected products: Infinity™ 7 Implantable Pulse Generator; Lot or serial number: More than 100 numbers, contact manufacturer.; Model or catalogue number: 6662
The hazard
Abbott is sharing important information regarding the Infinity™ Deep Brain Stimulation (DBS) Neurostimulation System, Proclaim™ Spinal Cord Stimulation (SCS) and Proclaim™ Dorsal Root Ganglion (DRG) Neurostimulation Systems. The purpose of this communication is to remind health care providers that the systems contain a Surgery Mode feature designed to help protect the implanted device from potential interference associated with the use of electrosurgical units (ESUs) during certain surgical procedures.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States