Medtronic Recalls Steerable Sheath Due to Debris
Medtronic is voluntarily recalling its FlexCath Select Steerable Sheath (10 Fr Select) after reports that debris was seen on some of the devices.
The Class I recall began last month following four reports of debris emanating from the hemostasis valve on the proximal end of the Model 990065 sheath. No serious injuries or deaths have been reported, the company said.
FlexCath is a single-use device for the percutaneous introduction of catheters into the heart and surrounding vasculature.
Medtronic told customers to stop using affected products and return them to the company. A spokesperson says there are currently no more devices in circulation.
See the recall notice at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134194. — Jason Scott