FDA: Class I Recall for Medtronic’s 6-Fr Sherpa NX Guide Catheter
The guide catheter may splinter during procedures, resulting in exposed wires and device fragments left behind, says the agency.
Medtronic has recalled all models of the 6-Fr Sherpa NX active guide catheter over concerns that the device’s outer material could separate and break off during procedures, which would result in exposure of the stainless-steel braid wires and device fragments left behind.
Yesterday, the US Food and Drug Administration identified this as a Class I recall, the most serious type, because of concerns about patient harm or death.
Fragments left behind after separating from the guide catheter, or attempts 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,” according to the agency.
The company has received five complaints about the Sherpa NX guide catheter, but there have been no serious injuries or deaths reported.
Medtronic first alerted hospitals about the device defect on March 15, 2019, and recommended the guide catheter be quarantined and/or returned. A month later, they sent a revised urgent medical device recall notice to hospitals recommending removal of the product. So far, Medtronic has recalled 106,298 devices manufactured in the United States between March 10, 2017, and March 14, 2019.
Food and Drug Administration. Medtronic recalls 6 French Sherpa NX active guide catheters due to separation and fragmentation issue. Published on: October 8, 2019. Accessed on: October 9, 2019.