Safety Alert Resource Center

FDA Safety Communication- ZOLL LiveVest 4000 - (1/17/2018) The US Food and Drug Administration (FDA) issued a safety communication for the ZOLL LifeVest 4000, which may fail to deliver appropriate therapy if the device shows the following error message: "Call for service: Device has a problem that may require service. Call ZOLL for service, Message Code 102." Learn more

Abbott: Battery Performance Alert for ICDs- (08/29/17) - Abbott has released a new Battery Performance Alert (BPA), that provides an earlier notification of abnormal battery performance that may lead to premature battery depletion due to short circuits from lithium clusters. The software patch is available on the St. Jude Programmer and on Merlin.net. Learn more

Abbott Cybersecurity Advisory- (08/29/17): On August 29, Abbott and the Food and Drug Administration each released a public safety communication regarding the availability of a pacemaker software patch to address a cybersecurity risk. The identified risk could allow unauthorized access to pacemakers that utilize radio frequency (RF) communications. Learn more

FDA Warning Letter to Abbott (St Jude Medical Inc.)- (04/17/2017)- On April 12th, 2017 the U.S. Food and Drug Administration (FDA) issued notification to Abbott (St Jude Medical Inc.) that they were in violation of 4 codes of federal regulations (CFRs).  This notification was part of the enforcement phase of the FDA’s ongoing investigation of issues with Abbott’s (St Jude Medical Inc.) ICD pulse generators and transmitters. Learn more

St. Jude Merlin@home Transmitter (01/09/2017) - The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) issued a safety communication regarding a cybersecurity vulnerability of the St. Jude Merlin@home Transmitter. Learn more

Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices (10/11/2016)- 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 of St. Jude Medical ICD and CRT-D devices. Learn more