St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.

The firm, Abbott, sent an "URGENT MEDICAL DEVICE CORRECTION" letters dated 05/18/2018, to its consignees notifying them that updated programmer software version 24.2.x will be made available over the next several weeks and will allow physicians to detect the presence of incorrect battery indicator prior to implant. Additionally, the programmer software will provide a mechanism to resolve the incorrect display for already implanted devices. If a low battery indicator is observed, customers were advised to contact firm technical services at 1-800-722-3774 to assist in confirmation and correction of the battery indicator display.