USA- Tctmd.com writes that Medtronic has issued a recall of its 6-Fr Sherpa NX active guide catheters after finding that the device’s outer coating can break off during procedures and leave the patient exposed to the metal wires and also leave fragments in the person once the device is removed.
The FDA has classified the recall as a Class I, which is only used in the most severe cases when the use of the device presents risks of harm or death.
The fragments the device can leave behind, and the attempts to retrieve those fragments, can cause a patient to suffer blocked blood vessels, injuries to their blood vessel walls, development of blood clots, heart attacks, embolisms, and even death.
There have been five complaints regarding issues with the catheter so far.
Medical device manufacturers often recall devices when they present risks to the patients who use them. Medical devices are complicated, and if something is wrong with the device, the results can be lethal for patients.
If a person is injured by a defective medical product, the injured person may be able to collect compensation from the manufacturer of the medical device. These liability cases help to keep medical device companies vigilant when it comes to ensuring their products are safe for their intended purposes. It is essential to note that just because a company recalls a product, does not mean that they are protected from being held liable for injuries the product causes to patients. While a recall can help preserve a company image and can prevent future injuries from a product, in many cases, people have already been harmed and can seek compensation from the company that made the defective device.
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