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Friday, June 12, 2009
Medtronic Pacemakers Elevated to a Class One Recall
The FDA announced yesterday that it was issuing a Class I recall of certain Medtronic Kappa and Sigma pacemakers. The products can fail due to a separation of wires that connect the components of the pacemaker, such as the battery, to the electronic circuit of the pacemaker.
The FDA changed the classification of the pacemakers from last month’s “physician advisory” to a Class I recall. There are currently lawsuits filed all over the country by consumers that were harmed by another one of Medtronic’s products, the Sprint Fidelis defibrillator, which has since been recalled.
There are more than 1.7 million Medtronic pacemakers implanted into people in the United States. Of those, only about 21,000 are affected by this recall. Most of those devices that have been recalled have been implanted in patients for five years or longer. The products that are being recalled are Kappa series 600/700/900 and Sigma series 100/200/300.
Patients with malfunctioning pacemakers may experience symptoms such as an abnormal heart rate, light-headedness or dizziness, and in rare cases, serious injury or death.
To find out if your pacemaker has been recalled, contact Medtronic at 1-800-505-4636, or go to their website at: http://www.kappasigmasnlist.com/.
For more information, see the FDA recall at:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm165619.htm
See the FDA Press Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165853.htm
The FDA changed the classification of the pacemakers from last month’s “physician advisory” to a Class I recall. There are currently lawsuits filed all over the country by consumers that were harmed by another one of Medtronic’s products, the Sprint Fidelis defibrillator, which has since been recalled.
There are more than 1.7 million Medtronic pacemakers implanted into people in the United States. Of those, only about 21,000 are affected by this recall. Most of those devices that have been recalled have been implanted in patients for five years or longer. The products that are being recalled are Kappa series 600/700/900 and Sigma series 100/200/300.
Patients with malfunctioning pacemakers may experience symptoms such as an abnormal heart rate, light-headedness or dizziness, and in rare cases, serious injury or death.
To find out if your pacemaker has been recalled, contact Medtronic at 1-800-505-4636, or go to their website at: http://www.kappasigmasnlist.com/.
For more information, see the FDA recall at:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm165619.htm
See the FDA Press Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165853.htm
Labels: FDA, Kappa, medical device, Medtronic, Pacemaker, Sigma, Sprint Fidelis
posted by
Colleen
at
2:21 PM
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