Defective Medical Products Comments Off on FDA Issues Warning on Medtronic Devices
Federal health officials have issued a defective product recall for about 15,000 Medtronic guide wires used in heart procedures. According to a USA Today news report, the recall was issued after Medtronic received four serious complaints. Officials say that the defects are severe enough to cause injury or death. The guide wires involved in this recall are inserted through an artery and are used to guide other devices into place, such as stents to hold open blocked arteries.
Potential for Serious Injury or Death
In one complaint involving this device, a patient went into cardiac arrest but was resuscitated. The recall notice warned hospitals and distributors worldwide that the coating on the guide wires could break off, which could increase the possibility of blocking a blood vessel. The coating on the wires is meant to make them slide through the blood vessels more easily. The FDA has classified this as a Class I recall, a category reserved for defective products with the potential to cause serious injury or death.
Medtronic, which is based in Minneapolis, said the recall affected certain lots of the products manufactured since April. The company said it has taken steps to prevent new shipment of the wires and has notified regulators globally. Any problems with the defective medical devices can be reported by calling 1-877-526-7890 or to the FDA’s web site at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.
Defective Medical Devices
Flaws in medical devices may occur due to manufacturing defects, defective design or defective marketing. If you have been injured or have suffered a loss as the result of a defective medical device, a number of parties may be held liable. The manufacturing company, a testing lab, a medical sales representative, medical clinic or doctor, may all be potentially liable parties in a product liability lawsuit involving a faulty medical device.
If you have been injured as a result of using a faulty medical device, an experienced product liability attorney can help you prove that the device was faulty and caused your injuries. All product manufacturers have a legal obligation to consumers to manufacturer products that are safe and of good quality. When they fail to do so, they can and should be held accountable. Injured victims in such cases can seek compensation for damages such as medical expenses, lost wages, hospitalization, pain and suffering and emotional distress.