FDA-Device2014-02-05Class II
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.
Boston Scientific Corporation
Hazard
Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.
Sold states
US Nationwide Distribution and Mexico
Affected count
1068 single units
Manufactured in
47215 Lakeview Blvd, Fremont, CA, United States
Products
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0900-2014Don't want to check this manually?
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