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In Excess of 70,000 Kids Injured due to Defective Medical Devices

Monday, July 26, 2010

Many people associate defective medical devices with adult patient injuries. Results from the first detailed national estimate suggests that more than 70,000 children and teens go to the emergency room each year for injuries and complications from medical devices, and contact lenses are the leading culprit, according to a recent…

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Cook Medical Recalls Tracheostomy Devices

Friday, July 23, 2010

According to FDA.gov, Cook Medical, Inc, has initiated a voluntary recall of certain lots of its Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that contain a Covidien 6PERC or 8PERC Shiley™ Tracheostomy Tube. Covidien has initiated a voluntary recall of certain lots of its…

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Defibrillators Warning Issued by Boston Scientific

Friday, July 23, 2010

Boston Scientific Corp. warned physicians that three of its implantable defibrillators have a defect that can prevent them from working properly, in the latest problem for the company's heart devices, according to a recent Reuters news report. A magnetic switch on the implantable cardiac defibrillators can get stuck, stopping the…

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FDA Warns Medical Device Manufacturer over Unlawful Promotion

Tuesday, May 11, 2010

The FDA recently accused medical-device manufacturer St. Jude Medical Inc. of violating the law by promoting and marketing its Epicor "surgical ablation" devices to treat a common heart-rhythm disorder without federal approval, according to a recent Wall Street Journal news report. Scores of surgeons use ablation devices made by St.…

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FDA Orders Baxter to Recall Infusion Pumps

Tuesday, May 04, 2010

On May 3, 2010, Baxter International Inc. announced a recall of nearly 200,000 Colleague brand drug-infusion pumps that are on the market, after years of malfunctions with the device, along with patient injuries and deaths, according to a recent Wall Street Journal news report. Baxter, said the recall was requested…

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Medtronic Lifepak Heart Devices Recalled

Friday, April 23, 2010

On April 22, 2010, FDA officials announced that Medtronic Inc. is recalling some of its Lifepak heart monitor and external defibrillators because the devices can unexpectedly turn on and off, according to a recent Reuters news report. In a statement, the FDA said it considered the recall of Medtronic's Lifepak…

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