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Defective Medical Devices

Recent Posts in Defective Medical Devices Category

  • DePuy's Pinnacle Hip Implant System To Be Tried In Court Once Again

    According to a recent court order, a group of ten cases, this time with New York plaintiffs, are currently being worked up for another bellwether trial scheduled to take place in September of this year. Expert disclosures have been submitted by all parties and depositions are scheduled to take place in the upcoming weeks. These plaintiffs and thousands of other people are alleging serious injuries ...
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  • Are IVC Filters Overused? New Study Sheds Light On Possible Complications.

    A recent study published in the JAMA Surgery journal suggests that IVC filters – commonly thought of as life-saving devices – might not be the safest option for some patients; especially those who didn’t need them in the first place. After thorough studies conducted over multiple years, researchers reported that the “indiscriminate use of IVCFs without clear indications places patients at risk of ...
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  • Essure Complaints Rise

    Essure is a kind of permanent, less-invasive sterilization procedure that women who want to avoid pregnancy have the option to use. The device is a coil designed to cause fibrosis and block the fallopian tubes to prevent fertilization. Many women who decided to use this option wanted to have a less invasive alternative to hysterectomy, or a complete removal of the uterus. However, thousands of ...
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  • Dangers of Atrium C-QUR Hernia Mesh

    Serious complications have been reported among patients implanted with Atrium C-QUR hernia mesh. Used to treat patients in need of hernia repair and reconstruction, C-QUR is different from many other mesh products out there in that its omega 3 gel coating is “all natural” and derived from fish oil. However, this coating – meant to reduce scar tissue and help the mesh stay affixed to the abdominal ...
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  • Endoscope Infections Widespread in Hospitals & Medical Centers

    Severe infections in hospital patients around the country have been attributed to unclean and unsterilized endoscopes used in surgeries and routine examinations. It is believed that more than 30 patients have died in the last three years as a direct result of endoscope infections. The Food and Drug Administration (FDA) is investigating the causes and consequences. Unclean Clinic Conditions & Bad ...
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  • St. Jude Heart Devices Vulnerable to Hacking

    Although shareholders of St. Jude Medical Inc. (STJ) recently approved a $25 billion merger between the company and Abbot Laboratories (ABT), the medical device manufacturer is still facing considerable backlash over accusations that its cardiac implants can potentially be hacked. The issue was first brought to light in August 2016 when short seller Carson Block of Muddy Waters LLC issued a ...
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  • 12 Hospitals Cited by FDA for Failing to Report Medical Device Safety Issues

    According to an article recently published by NPR , The Food and Drug Administration (FDA) has concluded that several major hospitals throughout the country are failing to accurately report patient deaths or injuries related to defective medical devices . As revealed in the FDA’s most recent hospital inspection report, reporting lapses were found in 12 hospitals surveyed throughout the country, ...
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  • New American Medical Study Concludes IVC Filters Have No Benefits

    Retrievable IVC filters have recently been the center of numerous lawsuits for causing painful and often fatal side effects in patients. Adding insult to injury, so to speak, the Journal of the American Medical Association (JAMA) has recently published a study that concluded IVC filters bring no measurable benefits even when they are fully functional. (You can view a summary of their study by ...
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  • Olympus Medical Scopes May Have Caused Dozens of Patient Deaths

    Olympus Corporation of Japan (Olympus) is at the center of an ongoing investigation and will likely be targeted by a series of lawsuits due to tainted or infected duodenoscopes it manufactured. The infected duodenoscopes are thought to be the cause of at least 35 patient deaths in 2013. A duodenoscope is a tube-like medical device that is inserted into a patient’s mouth and snaked down to the ...
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  • Recent News on Essure Lawsuits, August 2016

    Although the birth control device Essure was approved by the Food and Drug Administration (FDA) in 2002, the relative safety of the device is still under scrutiny. A noticeable percentage of women who have used Essure will develop some sort of negative symptom. In some cases, the consequence is a rash or hives caused by a nickel allergy; in others, it may cause vaginal bleeding or perforation that ...
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  • The FDA Updates IVC Filter Health Risk Warning

    Inferior vena cava (IVC) filters have drawn heavy criticism and numerous lawsuits by patients who claim to have incurred injuries due device failure, manufacturer negligence, defective design, and misrepresentation. The U.S. Food and Drug Administration (FDA) has updated its communication warning of these potential health risks and has stated that IVC filters should generally not be kept in use ...
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  • What You Should Know About Laparoscopic Power Morcellators

    Laparoscopic power morcellators have garnered a negative reputation in recent years as being far more dangerous than they are useful. But why? What do morcellators do that has the Food and Drug Administration (FDA) worried and doctors across the country extremely hesitant to even get near one of the devices? To get to the bottom of the issue, there are a few frequently asked questions about power ...
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  • Intra-Aortic Balloon Catheter Attorneys

    On February 11, 2016, Arrow International, a division of Teleflex, announced a global recall of its Intra-Aortic Balloon (IAB) Catheter Kits and Percutaneous Insertion Kits. The recall was initiated on February 9, 2016. Arrow International first received approval for IABs in 1996 as 510k devices. The FDA’s 510k process allows manufacturers to bypass clinical testing as long as the device is ...
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  • FDA ISSUES RECALL NOTICE ABOUT QUEST MEDICAL'S MPS DELIVERY SETS

    The FDA recently warned healthcare professionals of a recall of MPS Delivery Sets by Quest Medical, Inc. The Sets are used to deliver solutions to the heart during cardiopulmonary bypass surgeries. Quest Medical has recalled certain lots of these defective medical devices that were distributed between June 2015 and September 2015. The reason for the nationwide recall is a "seal failure along the ...
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  • FDA ISSUES RECALL NOTICE ABOUT SYNCARDIA'S FREEDOM DRIVER SYSTEM

    The FDA recently warned healthcare professionals of a recall of Freedom Driver System by SynCardia Systems. The Freedom Driver System operates and monitors SynCardia's Total Artificial Heart, which serves as a temporary "mechanical replacement for a patient's heart." SynCardia Systems has recalled certain lots of these defective medical devices that were distributed between November 2014 and July ...
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  • FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL'S ENDOBRONCHIAL TUBES

    The FDA recently warned healthcare professionals of a recall of Hudson RCI Endobronchial Tube by Teleflex Medical. These tubes are inserted through the mouth into the bronchi of the lungs and are "used during a medical procedure that determines how well a lung is working." In the US alone, Teleflex Medical has recalled over 62,000 of these defective medical devices that were distributed between ...
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  • FDA ISSUES RECALL NOTICE ABOUT COOK MEDICAL'S ANGIOGRAPHIC CATHETERS

    By Kaiser Gornick LLP posted in Defective Medical Devices on Monday, August 17, 2015 The FDA recently warned healthcare professionals of a recall of Beacon Tip Angiographic Catheters by Cook Medical. These angiographic catheters "are used to inject contrast dye into blood vessels in the heart to prepare it for a type of X-ray used to diagnose heart conditions." In the US alone, Cook Medical has ...
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  • FDA ISSUES RECALL NOTICE ABOUT TIGERPAW SYSTEM II

    The FDA recently warned healthcare professionals of a recall of TigerPaw System II by Maquet Medical Systems. The TigerPaw System II "is a surgical staple used to close tissue in the left atrial appendage," a muscular ear-shaped pouch in the heart. Maquet Medical Systems has recalled all lots of these medical devices that were distributed between April 2013 and March 2015. The reason for the ...
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  • FDA ISSUES RECALL NOTICE ABOUT HOSPIRA INFUSION PUMPS

    The FDA recently warned healthcare professionals of a recall of Plum A+ and Plum A+3 Infusion Systems by Hospira. These devices are used to deliver fluids, including "critical intravenous medication... into a patient's body in controlled amounts." Hospira has recalled infusion pumps manufactures and distributed between July 2012 and May 2014. The reason for the recall is faulty alarms that may ...
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  • FDA ISSUES RECALL NOTICE ABOUT TELEFLEX MEDICAL MAQUET SERVO HUMIDIFIER

    The FDA recently warned healthcare professionals of a recall of MAQUET Servo Humidifier 163 by Teleflex Medical. These devices are "placed over a surgically-created opening in the throat or a tube inserted into the trachea to warm and moisten gases breathed in by a patient." Teleflex Medical has recalled certain lots of the humidifiers distributed between June 2013 and November 2014. The reason ...
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  • FDA ISSUES SAFETY ALERT ABOUT INFECTION RISKS WITH DUODENOSCOPES

    The FDA recently issued a safety communication about potentially serious health risks associated with the use of ERCP endoscopes (also called duodenoscopes). These medical devices are "flexible, lighted tubes that are threaded through the mouth, throat, stomach, [in order to reach] the small intestine [or duodenum]." Their use "allows the injection of contrast dye [for imaging] or the insertion of ...
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  • FDA STRENGTHENS MARKETING REQUIREMENTS FOR DEFIBRILLATORS AFTER NUMEROUS DEVICE FAILURES

    The FDA recently issued a final order requiring "more rigorous review" of automated external defibrillators (AEDs) in order to improve the safety and reliability of such medical devices on the market. AEDs are portable devices used to "provid[e] a rapid response to victims of cardiac arrest" by "automatically analyz[ing] the heart rhythm... and deliver[ing] an electrical shock to the heart to ...
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  • FDA ISSUES RECALL NOTICE ABOUT KIMVENT* MICROCUFF* ENDOTRACHEAL TUBES

    The FDA recently warned healthcare professionals of a recall of Halyard Health's KimVent* Microcuff* Endotracheal Tubes. These devices are plastic tubes "inserted into the windpipe (trachea)... to open an airway for mechanical breathing [or]... to remove fluid that builds up in the windpipe during a procedure." Halyard Health has recalled endotracheal tubes distributed between December 2013 and ...
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  • FDA ISSUES RECALL NOTICE ABOUT SIEMENS RAPID GRAM NEGATIVE COMBO PANELS

    The FDA recently warned healthcare professionals of a recall of Siemens Healthcare Rapid Gram Negative Combo Panels. These devices are used to measure how certain bacteria respond to various types of antibiotics. Siemens Healthcare has recalled combo panels distributed between December 2013 and September 2014. The reason for the recall is that using the devices may lead to incorrect test results ...
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  • FDA ISSUES RECALL NOTICE ABOUT GEMSTAR INFUSION PUMP POWER SUPPLY

    The FDA recently warned healthcare professionals of a recall of Hospira's Wall Mount and Desk Top GemStar Power Supplies. These accessories provide power to the GemStar Infusion Pump, which is "used to deliver controlled amounts of fluids including medicines, blood, [and] nutritional foods... into a patient's body..." Hospira has recalled power supplies distributed between November 2011 and April ...
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