Shows & Panels
Shows & Panels
- The 2014 Big Picture on Cyber Security
- AFCEA Answers
- American Readiness: Renewable Power and Efficiency Technologies
- Ask the CIO
- Building the Hybrid Cloud
- Connected Government: How to Build and Procure Network Services for the Future
- Continuing Diagnostics and Mitigation: Discussion of Progress and Next Steps
- Federal Executive Forum
- Federal News Radio's National Cyber Security Awareness Month Special Panel Discussion
- Federal Tech Talk
- The Future of Government Data Centers
- The Future of IT: How CIOs Can Enable the Service-Oriented Enterprise
- Government Perspectives on Mobility and the Cloud
- The Intersection: Where Technology Meets Transformation
- Maximizing ROI Through Data Center Consolidation
- Mitigating Insider Threats in Virtual & Cloud Environments
- Modern Mission Critical Series
- The New Generation of Database
- Reimagining the Next Generation of Government
- Targeting Advanced Threats: Proven Methods from Detection through Remediation
- Transformative Technology: Desktop Virtualization in Government
- The Truth About IT Opex and Software Defined Networking
- Air Traffic Management Transformation Report
- Cloud First Report
- General Dynamics IT Enterprise Center
- Gov Cloud Minute
- Government in Technology Series
- Homeland Security Cybersecurity Market Report
- National Cybersecurity Awareness Month
- Technology Insights
- The Cyber Security Report
- The Next Generation Cyber Security Experts
Shows & Panels
FDA issues stern warning on Medtronic devices
Tuesday - 11/19/2013, 10:36pm EST
Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death.
The warning covers about 15,000 recalled guidewires, which are inserted through an artery and used to guide other devices into place, such as stents to hold open blocked arteries.
A recall of the guidewires began Oct. 21 after Medtronic received reports of four complaints, including one patient who went into cardiac arrest but was resuscitated, company spokesman Joseph McGrath said Saturday.
The recall notice warned hospitals and distributors worldwide that coating on the guidewires could break off, which could raise the possibility of blocking a blood vessel. The wires are coated to make them slide through blood vessels more easily.
Medtronic announced Friday night that the Food and Drug Administration had classified the recall as Class I, a category reserved for products with reasonable potential to cause serious injury or death.
The Minneapolis company said the recall affected certain lots made since April. The company said it has taken steps to prevent new shipments of the wires. It also has notified regulators around the world.
Problems with the guide wires can be reported to Medtronic by calling 877-526-7890 during weekdays from 8 a.m. to 5 p.m. CST; adverse reactions or quality problems can be reported to the FDA at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm
Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.