Lawyers and Settlements
Advertisement
Home Page >> Potential Lawsuit >> FDA Issues Corrective Recalls over St. Jude Pacemakers Cyber Security

FDA Issues Corrective Recalls over St. Jude Pacemakers Cyber Security


Santa Clara, CA: The US Food and Drug Administration (FDA) has issued a recall specifically for corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers.

The firmware update will be available beginning August 29, 2017. Pacemakers manufactured beginning August 28, 2017 will have this update pre-loaded in the device and will not need the update.

The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's RF-enabled implantable cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user (i.e. someone other than the patient's physician) to access a patient's device using commercially available equipment. This access could be used to modify programming commands to the implanted pacemaker, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.

Many medical devices, including St. Jude Medical's implantable cardiac pacemakers, contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.



Legal Help

If you or a loved one has suffered similar damages or injuries, please fill in our form and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on Aug-29-17

FDA ISSUES CORRECTIVE RECALLS OVER ST. JUDE PACEMAKERS CYBER SEC LEGAL ARTICLES AND INTERVIEWS

The Fix is In for St. Jude Defective Batteries, But Is it Enough?
The Fix is In for St. Jude Defective Batteries, But Is it Enough?
November 9, 2017
Washington, DC: The announcement last month of a new software tool capable of alerting patients with defective St. Jude cardiac defibrillators when a battery is in danger of failing prematurely may be too little, too late for patients who have suffered adverse events when defective defibrillator batteries failed too soon. Many have filed St. Jude ICD and CRT-D device lawsuits over the issue [READ MORE]

Criticism for Both St. Jude Medical and FDA over Defective St. Jude ICD Batteries
Criticism for Both St. Jude Medical and FDA over Defective St. Jude ICD Batteries
October 20, 2017
Washington, DC: A troubling report that ran in The New York Times back in April shed a dark shadow on defective St. Jude cardiac defibrillators and the batteries that powered them. St Jude ICD and CRT-D device lawsuits have alleged further than the original manufacturer of the medical devices, St. Jude Medical, downplayed reports of device failure for years. And it’s not just St. Jude lawsuit plaintiffs making that allegation; so too, is the US Food and Drug Administration (FDA), according to The New York Times (04/13/17) [READ MORE]

Were Defective St. Jude Cardiac Defibrillators Implanted Even After Recall?
Were Defective St. Jude Cardiac Defibrillators Implanted Even After Recall?
October 9, 2017
Washington, DC: The complaint in the ASEA/AFSCME Local 52 Health Benefits Trust defective St Jude cardiac defibrillator lawsuit contains shocking new allegations. The fact-finding that follows may give patients the information they need to seek redress [READ MORE]



READER COMMENTS

Posted by
Diana S. Yockey
on
I WISH They had done this when my GrandMother SUFFERED SO !!!!! THEY put her through HELL for 3 more years before she died !!!!!!!!!!!!! I HOPE THEY PAY DEARLY !!!!!!!!!!!

ADD YOUR COMMENT ON THIS ISSUE

Fields marked * are mandatory. Please read our comment guidelines before posting.

*Name:

Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.

*Your Comment:

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.

Request FDA Issues Corrective Recalls over St. Jude Pacemakers Cyber Sec Legal Help

First name:

Last name:

Email address:

Phone number(s):

Zip/Postal Code:

Defendant:
Describe your complaint:

By submitting this form I agree to the Terms of Service.
There is no cost to submit this form.
I would like to be interviewed by a journalist.
Receive our weekly newsletter with the latest lawsuit news and legal information.


Related Lawsuits

Legal Services:

Advertisement
 
FAQ | TOS | Privacy | Disclaimer | About Us | Contact Us | Press | Advertise | Member Login | Site Map | View Mobile Website

American Bar Association - Proud Member   Better Business Bureau   CAALA   Best of the Web Approved   Public Justice


This work is licensed under a Creative Commons Attribution-NoDerivs 3.0 Unported License © 2001-2017 Online Legal Media. All rights reserved.


Visit other Online Legal Media Websites:

BigClassAction.comCALaborLawNews.com
OnlineLegalMarketing.comHealthEffectsOfAsbestos.com