FDA recalls sheaths used for caths

The FDA issued a class 1 recall on Medtronic’s 10 French FlexCath Select Steerable Sheath, citing problems that may occur with the device outside a patient’s body.

The FDA reported no injuries or deaths related to the device.

Medtronic received four reports of apparent material separation with the sheaths, which are used for percutaneous cardiac catheterization procedures. “Clinicians observed debris appearing to originate from the hemostasis valve on the proximal end of Model 990065 FlexCath Select Steerable Sheath (10 Fr), outside of the patients’ bodies,” the FDA wrote.

In February, Medtronic hand-delivered recall letters to customers.

The affected sheaths have lot numbers 54790, 54860, 54876, 54877, 54878, 72417 and 72419.

Candace Stuart, Contributor

Around the web

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.