A study published on November 3, 2020 in JAMA Network entitled “Association Between Industry Payments to Physicians and Device Selection in ICD Implantation” concluded: “In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians… Read More
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FDA Announces Voluntary Recall Of Two Coronary Catheters
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… Read More
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Class I Recall Of More Than 322,000 Medtronic MiniMed Insulin Pumps For Incorrect Insulin Dosing
The FDA announced on February 12, 2020 a Class I recall of 322,005 MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) (all lots before October 2019) and Model 670G (MMT-1780) (all lots before August 2019). The distribution dates for Model… Read More
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FDA Issues Safety Communication Regarding Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors
The FDA issued a Safety Communication on March 21, 2019 entitled “Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors” “to alert health care providers and patients about cybersecurity vulnerabilities identified in a wireless telemetry technology used for… Read More
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$33.2 Million Settlement For Defective Medical Testing Device
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… Read More
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Federal Judge Rejects Strict Liability For Defective Medical Device Claim
On July 15, 2015, a federal judge with the U.S. District Court for Eastern District of Pennsylvania held that the exclusion from strict liability for prescription drug claims should also apply to prescription medical device claims. Despite the fact that the Pennsylvania… Read More
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FDA Issues AED Safety Communication
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… Read More
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Kentucky $7.25 Million Jury Verdict For Failed Cochlear Implant
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… Read More
