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Wednesday, January 27, 2010
ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall
Food and Drug Administration (FDA) and e3 Endovascular, Inc. have announced a Class I Recall of the Trailblazer Support Catheter. So far, no deaths have been linked to the defective catheters, but this is the most serious classification of recalls, and was issued in connect with reported adverse events. So far, no deaths have been linked to the recalled, defective catheters. A class I recall means that the product carries a reasonable possibility of causing a serious adverse health event or death.
Recalled Catheters
The recalled catheters were used in endovascular applications. That means that they were inserted in veins or arteries, rather than being used in other types of applications such as for bladder evacuation.
The recalled Trailblazer Support Catheters may crack near the radioplaque marker band resulting in serious complications including:
- Insufficient oxygen supply to tissues
- Damage to blood vessels
- Heart attack
- Limb amputation
- Unplanned surgery
- Death
No deaths have been reported in connection with the recalled medical devices, but adverse health events have occurred. According to the press release, all of the recalled devices have been returned to ev3, Inc.
If You Have Been Injured By a Defective Medical Device
Injury by a defective medical device can have severe health consequences and can be fatal. If you have been injured by a defective medical device or a defective drug, you may be entitled to compensation for your medical bills and more.
If you believe that you or a loved one has been injured by a medical device that was discovered to be defective or dangerous in any way, please contact the experienced defective drug attorneys at Schlichter, Bogard & Denton serving clients nationwide.
posted by
Tiffany
at
3:19 PM
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