FDA recall Z-2432-2021

Product

Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C

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-2432-2021