Medtronic Catheters Recalled Due to Separation and Fragmentation Issues
On October 1, 2019, the U.S. Food and Drug Administration (FDA) announced that all models of the 6 French Sherpa NX active guide catheters manufactured by Medtronic needed to be recalled due to the significant risk that the affected catheters may malfunction, possibly causing serious adverse health consequences, and even death. Accordingly, the FDA has labeled this a Class I recall, its most serious designation reserved for products that pose a reasonable probability of severe injuries or death.
The affected Medtronic catheters are used to access veins and arteries to assist with the delivery of devices, drugs, or fluids into blood vessels near the heart. They have been found to lose fragments of their outer material, resulting in the exposure of the underlying stainless steel braid wires. Meanwhile, the separated fragments could enter the patient’s bloodstream. The fragments – or attempts to remove the fragments – could result in vessel blockage, injury to vessel walls, blood clots, embolism, heart attack, and death. Indeed, the FDA reports that Medtronic has at least received at least five customer complaints about the catheters.
If you or a loved one suffered injuries you believe were caused by the Medtronic 6 French Sherpa NX Active Guide Catheters, contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.