Dive Brief:
- Medtronic is recalling all models of its 6 French Sherpa NX Active Guide Catheter because of a risk the outer material may separate from the device in fractured pieces that could be left in the patient’s bloodstream, according to a notice Tuesday from FDA.
- The agency said a total of 106,298 of the devices are being recalled in the United States. The devices were distributed worldwide.
- No deaths or serious injuries were reported as a result of the issue, though Medtronic received five customer complaints. FDA identified the recall as Class I, its most serious categorization, due to the potential for serious injury or death.
Dive Insight:
The catheter under recall is used in coronary angioplasty procedures to treat atherosclerosis, a narrowing of the artery to the heart. The catheter supports the delivery of devices including stents and balloons and provides a vehicle for contrast injection and taking measurements, Medtronic said on its website. The device is also used in peripheral vascular systems and to administer drugs or fluids into blood vessels, according to the recall notice.
FDA said there is potential for extensive loss of segment material and exposure of underlying stainless steel braid wires. Detached fragments of separated outer material could enter the patient’s bloodstream.
The fragments, or attempts to retrieve the pieces, could result in continued vessel blockage, injury to vessel walls, development of blood clots, embolism, heart attack or death, the agency said.
The devices were manufactured between March 2017 and March 2019, and distributed between April 2017 and April 2019. Medtronic initiated the recall on March 15, 2019.
On June 15, Medtronic sent a revised urgent medical device recall notice to customers with instructions to remove the affected catheters from inventory and return them to the company.
Medtronic stressed that the recall does not affect the company’s Launcher Coronary Guide Catheter, nor its stents, balloons or other implantable devices.
