Category Archives: Recalled Medical Devices
Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components
Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...
Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery
An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.
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 ...
British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy
Statement issued urging healthcare professionals to give women information on birth defects when Depakote and other valproate medicines are used during pregnancy.
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 ...
Lawsuits over DePuy ASR Metal-on-Metal Hip Implants Continue to Mount
DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be hit with lawsuits over recalled metal-on-metal DePuy ASR hip implants. Just yesterday, the national law firm of Parker Waichman LLP announced it had filed yet another DePuy ASR hip implant lawsuit, this time on behalf of a Virginia resident ...
Australian Health Agency Issues Warning for Battery Problem with Medtronic InterStim Neurostimulation Devices
Warning for Medtronic InterStim Neurostimulation DevicesTGA has issued a safety warning for InterStim and InterStim II neurostimulation devices, because of possible early depletion of the battery.
Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent
Yet another study is confirming the association between the diabetes drug, Actos, and bladder cancer. This latest research, published today in the Canadian Medical Association Journal, found that taking Actos raised the risk of bladder cancer among diabetics by about one-fifth.
Actos Side Effects Lawyers Says Whistleblower Revelations Could Boost Bladder Cancer, Heart Failure Lawsuits
An attorney with a prominent personal injury law firm says an Actos whistleblower lawsuit filed earlier this year could strengthen legal claims alleging the type 2 diabetes medication caused some users to develop bladder cancer and heart failure.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
Boston Scientific Recalls Fetch 2 Aspiration Catheters
Boston Scientific has recalled all models of the Fetch 2 Aspiration Catheter. The U.S. Food and Drug Administration (FDA) has classified this as a Class 1 recall, the most serious type of recall where the FDA deems a reasonable probability … Continue reading
Jurors Hear Expert Testimony in DePuy Pinnacle Trial
The bellwether trial over injuries allegedly caused by the DePuy Pinnacle metal-on-metal hip implant continues in the Northern District of Texas. For the past four weeks, jurors have been hearing arguments over whether the hip replacements are to blame for … Continue reading
Arkray Recalls Glucose Test Strips Because of Inaccurate Readings
Arkray USA, which makes products for diabetes management, has announced the recall of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip used to test blood sugar (glucose) levels in patients with diabetes because these … Continue reading
