Category Archives: Recalled Medical Devices
Fracking Should be Kept 600m From Aquifers, Study Says
New research on the safety of hydraulic fracturing (fracking) suggests new wells should not be dug within 600 meters of a water aquifer because underground fractures can extend about that far from a dug well. According to a report from UK’s The Guardian newspaper, researchers and geologists at Durham University have ...
Birth Control Shot Depo-Provera may Increase HIV Risk, Study Suggests
A new study has linked the use of Depo-Provera (medroxyprogesterone acetate), an injectable type of birth control, to an increased risk of HIV infection.
Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business
Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...
Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting
An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...
West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels
A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...
Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications
A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...
Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures
In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...
Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda
A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...
Long Island Car Crash Kills 1 Person, Injures 2 More
A car accident on LI left one person dead & two more critically injured. The crash occurred Monday in Deer Park on Straight Path, south of Sagamore Lane.
Study Finds System for Tracking Prescription Drug Side Effects Flawed
System for keeping track of dangerous side effects of prescription drugs is flawed because drug makers are submitting incomplete information about problems to the FDA.Faulty St. Jude Riata Defibrillators may have Fatal Consequences
Patients who still have recalled St. Jude Defibrillators leads in their chests have many reasons to be vigilant. Premature insulation failure in the recalled device has been tentatively linked to polymicrobial endocarditis, a serious, often deadly condition that leads to … Continue reading
Cook Medical Recalls Medical Device due to Blood Clot Risk
The U.S. Food and Drug Administration (FDA) has identified the Cook Medical Zenith Alpha Thoracic Endovascular Graft as a Class I recall, the most serious type of recall where there is a “reasonable probability that the use of or exposure … Continue reading
St. Jude ICD Recall Is Deemed a Class I by Federal Regulators
St. Jude recently reported two patient deaths tied to early depletion of lithium batteries in St. Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D). The U.S. Food and Drug Administration (FDA) and St. Jude issued an … Continue reading
Teleflex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Use
Teleflex Medical has issued a recall for the Willy Rusch Tracheostomy Tube Set because the connector may disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, the … Continue reading
HeartWare International Heart Pump Subject to FDA Class 1 Recall
Medtronic has announced that the U.S. Food and Drug Administration (FDA) has classified two global voluntary recalls of HeartWare International’s HeartWare Ventricular Assist Device (HVAD) as Class 1 recalls. A class 1 recall is the FDA’s most serious recall category, … Continue reading
Medtronic Recalls Thousands of Lots of Various Neurovascular Products
Medtronic PLC just recalled certain lots of four of its neurovascular products. The device maker noted that the recalled devices might lead to a thromboembolic event (blood clot) in patients. The recalled Medtronic neurovascular products are: Pipeline Embolization Device (1742 … Continue reading
Medtronic Recalls Temporary Cardiac Lead Pacing Systems
The Food and Drug Administration (FDA) has announced a Class II designation for a recall involving thousands of Medtronic temporary lead pacing systems because there is the potential for them to connect to a hazardous voltage. The recall involves 11,697 of … Continue reading
Power Morcellators, Essure Birth Control System Prompt Introduction of Two Proposed Bills to Protect Consumers
House legislation has recently been introduced in an effort to prompt quicker action by federal regulators to remove dangerous medical devices from the market. Two bipartisan bills are expected to ease the process for patients who have suffered due to … Continue reading
Medtronic Recall for Respiratory Monitoring Battery Pack
A worldwide voluntary recall for the battery pack used in Medtronic’s Covidien Oridion labeled Capnostream 20 and Capnostream 20p Patient Monitor is being conducted due to a manufacturing defect that may increase the thermal damage in the battery pack. Battery … Continue reading
