FDA-Device2015-03-25Class I
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.
Medtronic Inc. Cardiac Rhythm Disease Management
Hazard
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
Sold states
Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.
Affected count
151 (4 US, 147 OUS)
Manufactured in
8200 Coral Sea St NE, Saint Paul, MN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1276-2015Don't want to check this manually?
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