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Safety Alerts
Software Update for LifeVest 4000 Wearable Cardioverter Defibrillator
(Jan 2019 Update) The FDA approved a new software for the ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code…
January 15, 2019
Safety Alerts
Safety Advisory: Boston Scientific First Generation S-ICD System SQ-RX™ Model 1010 Pulse Generators (PG)
Boston Scientific released a product advisory related to accelerated battery depletion and a shortened replacement interval observed in some of the first generation Subcutaneous Implantable…
November 5, 2018
Safety Alerts
Safety Advisory: Medtronic Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan Pacemakers
Medtronic released a software update to prevent possible device reset to RV only pacing at 65 bpm for the Percepta family of CRT pacemakers.
June 22, 2018
Safety Alerts
Safety Advisory Regarding Medtronic EnTrust ICDs
Medtronic announced an urgent medical device recall affecting approximately 2,770 (209 confirmed active in the U.S.) EnTrust ICDs due to the potential for loss of…
June 21, 2018
Safety Alerts
Abbott Advisory: Battery Performance and Firmware Update – April 2018
The US Food and Drug Administration (FDA) issued a Medical Device Safety Communication announcing a firmware update that addresses 2 previously reported safety concerns.
April 18, 2018
Safety Alerts
Medtronic Extends Voluntary Recall to Include 752 ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery
On March 16, 2018, Medtronic announced a voluntary recall affecting 752 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs).
March 19, 2018
Safety Alerts
Premature Battery Depletion – SJM ICD and CRT-D
On October 11 2016, the U.S. Food and Drug Administration issued a safety communication alerting health care providers and patients about premature battery depletion in a subset…
October 11, 2016
Safety Alerts
Medtronic Recalls 48 Individual ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery
The Food and Drug Administration (FDA) announced a recall of 48 individual Medtronic ICDs and CRT-Ds, identified by the devices’ serial numbers.
February 26, 2016
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