PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: September 22, 2021 Initiated: July 21, 2021 #Z-2432-2021

Product Description

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.

Details

Recalling Firm
Cordis Corporation
Units Affected
26025 units
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
Location
Miami Lakes, FL

Frequently Asked Questions

What product was recalled?
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C. Recalled by Cordis Corporation. Units affected: 26025 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 22, 2021. Severity: Critical. Recall number: Z-2432-2021.