FDAFebruary 23, 2015device
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
What to do
FDA enforcement status: Terminated
Brands named
medtronic inc cardiac rhythm disease managementmedtronicmedtronic inc
Recall history
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