Tag: FDA recall
US FDA issues alert over potential need for early device replacement...
The US Food and Drug Administration (FDA) has alerted patients, caregivers and healthcare providers about the potential need for early device replacement of Boston...
Medtronic disables internet updates in CareLink CIEDs due to cybersecurity risks
Medtronic has issued a software update "to address a safety risk caused by cybersecurity vulnerabilities" in 34,000 of their cardiac implantable electronic devices (CIEDs),...
Medtronic: class I recall- manufacturing error preventing electrical shock delivery
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to a defect in the manufacturing process. This defect...
Class I recall: HeartStart MRx defibrillator by Philips Electronics
Philips is recalling the HeartStart MRx defibrillator due to a defect in the device's gas discharge tube. The gas discharge tube has micro cracks...
FDA updates Class I recall of St. Jude Medical’s ICDs and...
In October 2016, St. Jude Medical recalled a subset of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to reports of...