FDA recall Z-2429-2021

Product

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

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.

Key facts

Status

Terminated

Initiation date

2021-07-21

Report date

2021-09-22

Termination date

2024-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

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