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.