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FDA: Medical Device Information For Consumers
Items added to the Center for Devices and Radiological Health's Consumer website within the last month.
Updated: 56 min 11 sec ago
Consumer Information on: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator - P110016
The Therapy Cool Path Duo? Ablation Catheter or the Safire BLU Duo? Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia2) called typical atrial..
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: M-Vu Algorithm Engine - P100005
The M-Vu Algorithm Engine is a software application designed to process digitized film images of the breast. The software analyzes the images and marks suspicious areas consistent with breast cancer for review by a radiologist. The results are displayed o
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems - P100039
ADVIA Centaur Anti-HBs2 (aHBs2) assay is a laboratory test used to detect antibodies associated with hepatitis B virus (HBV) infection.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: GORE TAG Thoracic Endoprosthesis - P040043/S040
The GORE TAG Thoracic Endoprosthesis is an artificial endovascular stent graft and is used to treat isolated lesions, excluding dissections, of the descending thoracic aorta during endovascular repair. Some of the complex isolated lesions include...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Respironics, Inc. Trilogy 100 Ventilators
Trilogy 100 ventilators are being recalled due to a manufacturing issue. This issue can cause part of the blower that circulates air and other gases through the ventilator to move out of position and cause the device to alarm and stop delivering therapy..
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) - H100004
The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or..
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer - P110031
The Elecsys® Anti-HBc IgM Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: BSD-2000 Hyperthermia System - H090002
The BSD-2000 Hyperthermia System is intended to deliver focused therapeutic heating (hyperthermia); with temperatures greater than 104 Fahrenheit (40 Celsius), to cancerous tumors by applying radiofrequency (RF) energy at the frequency range of 75 to...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Ikaria INOmax DS Drug Delivery System
Reason for Recall: Fretting corrosion at the electrical contact interface of certain metals was the root cause for erratic nitric oxide (NO) monitoring readings. Adverse consequences may include inadequate oxygen reaching the tissues in the body...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: CareFusion AVEA Ventilator
Reason for Recall: The AVEA ventilator can develop a failure where the ventilator activates a false Extended High Ppeak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer - P110025
The Elecsys® Anti-HBc IgM Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads
Failures associated with lead insulation abrasion on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads may cause the conductors to become externalized. If this occurs, this product may cause serious adverse health...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: AtriCure Synergy Ablation System - P100046
The AtriCure Synergy Ablation System is used to destroy (ablate) heart tissue that is beating abnormally. It includes the Synergy Ablation Clamp, a handheld surgical device that destroys the heart tissue that is grasped between the clamp?s jaws during...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: HER2 CISH pharmDx? Kit - P100024
The HER2 CISH pharmDx Kit is a laboratory test that uses DNA probes with chromogenic dyes attached to count how many copies of the HER2 gene, located on chromosome 17, are present in a cancer tissue sample. This test which uses a chromogenic in situ...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System - P110010
The PROMUS Element stent is a metal stent with the drug everolimus contained in a thin coating on the stent?s surface. The PROMUS Element stent is mounted on a folded balloon attached to a catheter delivery system for placement into a coronary artery...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: CooperVision AVAIRA Toric and Sphere Soft Contact Lenses
Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: CooperVision Avaira (enfilcon A) Sphere Soft Contact Lenses
Reason for Recall: The unintended presence of a silicone oil residue on AVAIRA Sphere soft contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Video: LASIK Surgery and its Risks
LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses. The goal of this Web site is to provide objective information to the public about LASIK surgery.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Class I Medical Device Recall: Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)
The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage. Additionally, there may be a 5-10 second delay between the electrocardiogram and blood pressure curves...
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Consumer Information on: NeuRx DPS?, Diaphragm Pacing System - H100006
The NeuRx Diaphragm Pacing System (DPS)? is a percutaneous, intramuscular, diaphragm motor point stimulating device intended for use in amyotrophic lateral sclerosis (ALS) patients with a stimulatable diaphragm (both right and left portions) as...
Categories: NEWS: U.S. Food and Drug Administration (FDA)