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Articles Posted in defective medical device

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Philips Respironics Recall: New Investigation Reveals Blatant Corporate Negligence

In a startling revelation brought to light by the investigative efforts of ProPublica and the Pittsburgh Post-Gazette, the Philips Respironics case has unveiled a disturbing narrative of corporate negligence. Over an 11-year period, this medical device manufacturer concealed mounting evidence of serious issues with its breathing machines, placing profit above…

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Product Liability and Patient Safety: The Philips Evo Ventilator Recall

Recent recalls by Philips have highlighted the importance of product liability and patient safety in the healthcare sector. The latest recall involves approximately 57,000 Evo ventilators due to issues with the machines’ air flow sensors. Philips’ Respironics unit has faced a series of recalls since 2021, initially related to soundproofing…

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The recent recall of defective Philipps sleep apnea ventilator devices demonstrates the inhability of the FDA at managing medical device recall

After a recent study pointed fingers at the mismanagement of medical device recall by the FDA (see previous blog),  further investigations are confirming an outdated and broken system that leaves patients at risk of serious injury and death as unaware doctors continue to use defective devices on their patients. A…

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HeartWare Ventricular Assist Device implanted in patients despite FDA knowledge of product being defective

Medtronic stopped the sale of the defective HeartWare Ventricular Assist Device, or HVAD last June after more than 3,000 patients died and 20,000 were injured. Since 2011, multiple problems with the device have been reported to the Food and Drug Administration but the agency never took any decisive action to…

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51 reports of personal injuries and one death prompt the FDA to announce an urgent Class I Recall of Maquet’s Tiger Paw System II, a medical device used during heart surgery

A defective surgical staple used to close tissue in the left atrial appendage of the heart is being recalled by the FDA after reports that patients suffered personal injuries such as tissue tears and bleeding  including a possible tear of the left atrial wall (top left chamber) during use of the…

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With the first product liability lawsuits being filed against duodenoscope manufacturers, it was diclosed today that the devices that led to the CRE outbreak at UCLA where not FDA approved

Patients and family of patients that have been infected by contaminated duodenoscopes at UCLA Hospital started  to file product liability lawsuits against Olympus, the manufacturer of the medical devices. 18 year old Aaron Young was the first one to file his lawsuit. The high school student is still hospitalized and receiving treatment for …

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To prevent personal injury or death related to defective automated external defibrillators, the FDA just announced that manufacturers will now be required to submit premarket approval applications for their new products

When a person is injured or dies because of an automated external defibrillator failure, it is often the result of a defective design or a manufacturing flaw such as the inadequate quality control of outsourced components. Automated External Defibrillators (AEDs) are usually stored in public places and ready for use…

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Product Liability – Defective Medical Device: FDA initiates Class 1 recall of some Bard LifeStent Solo Vascular Stents because they may fail to deploy

The defective stents may cause serious personal injury such as complications of bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death if they fail to deploy properly. The LifeStent Solo Vascular Stent manufactured by Bard Peripheral Vascular is an implantable self-expanding stent and delivery system used…

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