FDA News

FDA designates recall of guide catheter as class 1

The FDA has designated Medtronic’s product recall of a guide catheter as a class 1 recall, the most serious kind. The recall affects 106,298 guide catheters manufactured and distributed between March 10, 2017, and April 4, 2019.

Separation and fragmentation issues related to the guide catheter (6F Sherpa NX Active) may result in the exposure of underlying stainless-steel braid wires, according to a MedWatch report from the FDA. Fragments left in the patient’s bloodstream or attempts to retrieve them may cause serious adverse health consequences such as injury to blood vessel walls, continued blockage of blood vessels, blood clot development, MI, embolism or death.

The company has received five customer complaints associated with these issues, although there were no reports of deaths or injuries, according to the report.

Medtronic distributed a notice to customers June 15 alerting them to identify and remove any affected catheters from their inventory, and to return all affected products to the company.

This issue does not affect the company’s coronary guide catheter (Launcher) or other balloons, coronary stents or implantable devices, according to the report.

The FDA has designated Medtronic’s product recall of a guide catheter as a class 1 recall, the most serious kind. The recall affects 106,298 guide catheters manufactured and distributed between March 10, 2017, and April 4, 2019.

Separation and fragmentation issues related to the guide catheter (6F Sherpa NX Active) may result in the exposure of underlying stainless-steel braid wires, according to a MedWatch report from the FDA. Fragments left in the patient’s bloodstream or attempts to retrieve them may cause serious adverse health consequences such as injury to blood vessel walls, continued blockage of blood vessels, blood clot development, MI, embolism or death.

The company has received five customer complaints associated with these issues, although there were no reports of deaths or injuries, according to the report.

Medtronic distributed a notice to customers June 15 alerting them to identify and remove any affected catheters from their inventory, and to return all affected products to the company.

This issue does not affect the company’s coronary guide catheter (Launcher) or other balloons, coronary stents or implantable devices, according to the report.