FDA-Device2021-09-22Class I
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Cordis Corporation
Hazard
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
Affected count
71330 units
Manufactured in
14201 NW 60th Ave, N/A, Miami Lakes, FL, United States
Products
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2431-2021Don't want to check this manually?
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