Legal Updates
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…
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…
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…
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.…
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…
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…
