Medtronic announced on October 8, 2019 that it was recalling its 6 French Sherpa NX Active Guide Catheters due to a separation and fragmentation issue. The 6 French Sherpa NX Active Guide Catheter is used to access veins and arteries inside and outside of the heart (coronary and peripheral vascular systems). It may be used to assist with the placement and exchange of guidewires and other interventional devices and administer drugs or fluids into blood vessels. The primary users of this device are physicians.
Reason For The Recall
Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in the underlying stainless-steel braid wires being exposed. These fragments could be left inside the patient’s bloodstream, and this or the attempts made to retrieve the fractured pieces, can cause other serious adverse health consequences such as continued blockage of blood vessels, injury to blood vessel walls, development of blood clots, embolism, heart attack or death. Medtronic had received five customer complaints but no serious injuries or deaths were reported.
On June 15, 2019, Medtronic sent a Revised Urgent Medical Device Recall Notice to customers instructing them to identify and remove any affected catheters from inventory.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Medtronic states on its website: “Sherpa NX Active Coronary Guide Catheter is your solution for procedures that require consistent and durable performance. Percutaneous Coronary Intervention (PCI), also known as coronary angioplasty, is a therapeutic procedure to treat the narrowed or stenotic section of the coronary artery of the heart due to coronary atherosclerosis. The guide catheter provides support for device advancement (stents, balloons etc.). It is the conduit for device and wire transport, a vehicle for contrast injection and takes measurements. Guide catheters are available in a variety of shapes and sizes to fit a variety of patient anatomies.”
Medtronic further states on its website: “The Sherpa NX Active catheter has a soft tip and distal sleeve to enable manipulation … Robust, thinner walls without compromising support or curve retention … Workhorse performance suitable for various anatomies.”
Forbes reports on its website that “Medtronic’s total revenues grew from $28.8 billion in fiscal 2016 to $30.6 billion in fiscal 2019. This represents an average annual growth rate of 2.0%. We forecast the revenues to be around $33.6 billion by fiscal 2021, reflecting an average annual growth rate of 4.8%.”
If you or a loved one suffered harm due to a defective medical device or implant, such as a catheter, in the United States, you should promptly consult with a medical device injury lawyer in your U.S. state who may investigate your defective medical device claim for you and represent you or your loved one in a medical device claim, if appropriate.
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