A medical device is any piece of equipment instrument designed to diagnose or treat a medical condition. Every month, several medical devices are recalled by the American Food and Drug administration because of the potential to cause harm.
This is a list of recent Class 1 recalls. Class 1 recalls are the most serious type of FDA recall and involve situations in which there is a reasonable probability that use of the recalled product will cause adverse health effects or wrongful death.
List of 2010 FDA Medical Device Recalls (January-February)
02/26/10 Exelint International Inc. - Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion Sets: Inspections of the company’s facilities found that the needles "cored" in 60 to 72 percent of tests. The cores can cause the ports to leak and can potentially enter a patient’s body when the port is initially accessed and flushed. These issues may lead to decreased effectiveness of the port, replacement of the port, infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs. Death could occur.
02/26/10 StatSpin, Inc., doing business as IRIS Sample Processing, StatSpin Express 4 Centrifuges, Model #510: The rotor of the centrifuge may break and separate from the motor striking a safety microswitch so it fails to shut down the centrifuge. The loose rotor may strike the lid of the centrifuge housing which may cause the lid to open and eject pieces of the rotor. These pieces may cause serious physical injury to bystanders and may expose them to blood-borne infectious micro-organisms.
02/04/10 Thomas Medical Products Inc., Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport: The tip of the sheath may break off and separate while the sheath is inside a blood vessel. If this occurs, the tip could move through the blood vessel into organs such as the lungs and heart or into arteries. From there, the broken tip could cause a blockage anywhere in the body, leading to permanent injury, stroke or heart attack, or even death.
01/28/10 Hettich Instruments Management I, Hettich Centrifuges with 2050 and 2076 Plastic Rotors: The plastic centrifuge rotor in the centrifuge may crack, break apart and be forcefully ejected through the plastic centrifuge housing at a high rate of speed. This may result in serious personal injury and damage to the surrounding area.
01/28/10 Edwards Lifesciences Inc., Aquarius Hemodialysis System: Edwards Lifesciences issued an Urgent Product Recall for the hemodialysis system after receiving reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected, the Aquarius will trigger an alarm. Users are able to override this alarm and continue therapy making it possible to remove too much fluid from or replace too much fluid to the patient. In repeated cases, the imbalance increases, and may result in serious injuries or death to the patient.
01/05/10 ev3 Endovascular, Inc., Trailblazer Support Catheter: The device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death.
Have You Or A Loved One Been Injured By A Defective Medical Device?
If you or a loved one has been injured by a defective medical device you need to speak with an experienced defective medical device attorney as soon as possible. Please contact us online or call our Kansas City office directly at 816.471.5111 to schedule your free consultation.