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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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