FDA-Device2021-09-22Class I

Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB

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
1610 units
Manufactured in
14201 NW 60th Ave, N/A, Miami Lakes, FL, United States
Products
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2429-2021

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