Medtronic announced a recall of all models of its 6-French Sherpa NX Active Guide Catheters, and the U.S. Food and Drug Administration identified this as Class I, the most serious type of recall.
This catheter is used to access coronary and peripheral arteries and veins. It may be used to assist with the placement and exchange of guidewires and other interventional devices, as well as to administer drugs or fluids into blood vessels, according to the FDA’s recall notice, posted Tuesday.
Medtronic issued the recall because of a risk that the outer material might separate from the device, which could result in exposure of the underlying stainless steel braid wires, the FDA said. These fragments could be left inside the patient’s bloodstream, and these fragments or attempts to retrieve them can cause other serious adverse consequences such as continued blockage of blood vessels, injury o blood vessel walls, development of blood clots, embolism, heart attack or death, according to the notice.
A Class I recall refers to a situation in which there is reasonable probability that the use of, or exposure to, a recalled product will cause serious adverse health consequences or death, according to the FDA.
Medtronic has received five customer complaints; no serious injuries or deaths were reported.
The FDA said this issue does not affect the Medtronic Launcher Coronary Guide Catheter or other Medtronic coronary stents, balloons or implantable devices.
Medtronic sent a revised urgent medical device recall notice to customers on June 15, asking them to identify and remove any affected catheters from inventory and return any affected products to Medtronic.
Health-care professionals may contact their Medtronic field representative or Medtronic customer service at (888) 283-7868 for more information. Patients may contact Medtronic Cardiovascular Patient Services at (877) 526-7890 from 7:30 a.m. to 5 p.m. Central Time Monday through Friday. Problems may also be reported to the FDA’s MedWatch program.