FDA Announces Voluntary Recall Of Two Coronary Catheters
June 27, 2020
The FDA announced on February 20, 2020 that Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. The recall does [...]
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$33.2 Million Settlement For Defective Medical Testing Device
April 10, 2018
Patients and their doctors rely on the safety and effectiveness of medical testing devices when making decisions regarding diagnosis and medical care. Defective or faulty medical testing devices put patient safety at risk and may result in the wrong decisions being made regarding medical treatment, [...]
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FDA Issues AED Safety Communication
December 13, 2013
An AED (automated external defibrillator) is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Whe[...]
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Kentucky $7.25 Million Jury Verdict For Failed Cochlear Implant
April 20, 2013
On April 16, 2013, a federal jury in Kentucky returned a $7.25 million verdict in favor of a little girl whose cochlear implant (a surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf or severely hard of hearing) failed due to moisture leakage t[...]
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