#Atlas recall support serial numbers
#Atlas recall support update
#Atlas recall support upgrade

Physician Communication, Octo– ICD Premature Battery Depletion Advisory Update On October 11, 2016, we provided an important medical device advisory to physicians regarding ICD and CRT-D devices manufactured before for models Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra. Physician Communication – Battery Performance Alert Field Safety Notice Update The new Battery Performance Alert, which can be used as a patient management tool and is intended to help identify potential premature battery depletion in the following devices subject to the OctoMedical Device Advisory: Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™ pacemakers and CRT-P devices.

On August 29, 2017, as part of our commitment to continuous improvement, we have recently released an update intended to provide physicians with earlier warning of the potential for premature battery depletion due to short circuits from lithium clusters in patients’ implantable defibrillators.

#Atlas recall support serial numbers

Patients can also look up their serial numbers for their devices and learn more about remote monitoring options.īattery Performance Information for Patients This page includes important information about the new Battery Performance Alert update and responses to frequently asked questions. On April 16, 2018, we developed online information for patients. Physician Communication – Battery Performance Alert White Paper

#Atlas recall support upgrade

Physician Communication – Battery Performance Alert and Cybersecurity Firmware Upgrade for Certain ICD and CRT-D Devices Additionally, an alert will still continue to be provided to physicians through the remote monitoring system and the Merlin programmer during subsequent follow-up. This firmware upgrade now allows for device-based detection of abnormal battery performance and if BPA is triggered, a vibratory notification is delivered to the patient, thereby ensuring continuous monitoring in situations where adherence to transmission schedules is challenging (e.g. Until now, detection of this alert has only been available through the ™ remote monitoring system and the Merlin programmer during routine follow-up evaluations. We recently notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds).Īs communicated in August 2017, the Battery Performance Alert (BPA) algorithm is a management tool and is intended to provide earlier notification of abnormal battery performance for Battery Advisory Devices prior to premature battery depletion.

Medical Device Advisory: Premature Battery Depletion with Implantable Cardioverter Defibrillator – April 16, 2018 Physician Communication, Ap– HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Occlusion Model 106524 LVAS Kit, HM3 10012390GBL Important Medical Device Advisory On April 5, 2018, we provided an important medical device advisory regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Physician Communication, – HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Occlusion Model 106524 LVAS Kit, HM3 10012390GBL Updated Important Medical Device Advisory On May 21, 2018, we provided an update to the important medical device advisory regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Physician Communication, – HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Frequently Asked Questions We provided a frequently asked questions document for physician use as needed, to cover the most common questions relating to the HeartMate 3 Left Ventricular Assist System recall. On May 22, 2018, the FDA classified this medical device advisory as a Class I Recall. Physician Communication – HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Occlusion Model 106524 LVAS Kit, HM3 10012390GBL We have received FDA approval for the Outflow Graft Clip, designed to prevent any rotation of the outflow graft, thus addressing the safety concern reported in the May 2018 notice. Urgent Medical Device Recall: HeartMate 3 Left Ventricular Assist System – October 17, 2018Īn update to the previously communicated Class I Recall associated with the HeartMate 3 Left Ventricular Assist System.