Food and drugs (FDA) today announced the removal of a defective medical device used to "dilate" or enlargement, arterial injuries during certain surgeries. The product manufacturer, AngioScore, Inc., issued the recall after discovering a flaw in design that can lead to peeling of bail or detachment on the part of the instrument. These events could potentially lead to serious injury artery causing death or more require surgery.
The recall of AngioScore, affecting more than 17,000 units, involves the Angiosculpt percutaneous Transluminal angioplasty scoring balloon catheter; OTW 0.018 platform (various sizes), batch codes 2076-4020, 2076-5020, 2076-6020, 2092-6020 and 6020 2105. These devices are used for "dilation of lesions in the iliac, femoral, femoral, popliteal, ilia infrared arteries, popliteal and kidney and for the treatment of obstructive lesions dialysis natively or synthetic arteriovenous fistulas," according to the notice of recovery. AngioScore has advised its customers immediately suspend the use of instruments, check your inventory and quarantine units all affected.
Class I recalls is the most serious recall issued by the FDA. This type of recovery is reserved for medical devices and drugs posed an immediate risk of injury or death to patients. Any damage caused by a defective drug or medical device may be grounds for a personal injury lawsuit. An adverse medical or death caused by a defective product may also be grounds for a claim of death of a defective product.
For more information about claims of defective medical devices, please contact a personal injury lawyer or visit the YourLegalGuide.com section focusing on this topic.
This entry was posted on Wednesday, January 05, 2011 at 3: 53 pm and is filed in Uncategorized. You can follow any responses to this entry through the RSS 2.0 source. Comments and pings are currently closed.
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