Health product recall

SUPER TORQUE? MB Marker Band Flush Catheter (2021-07-23)

Starting date:
July 23, 2021
Posting date:
August 6, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-76167



Last updated:
2021-08-06

Affected Products 

SUPER TORQUE? MB Marker Band Flush Catheter

Reason

Cardinal Health is initiating an urgent medical device field correction to provide important information concerning the decision by Cordis to add the following contraindication to the Instructions For Use (IFU) for the Cordis Super Torque MB Angiographic Catheters:

Do not use the Super Torque MB Angiographic Catheters in procedures where entrapment of the catheter between endovascular devices and the vessel wall may occur.

Affected products

SUPER TORQUE? MB Marker Band Flush Catheter

Lot or serial number

All lots.

Model or catalog number

532-598A

532-598B

532-598C

Companies
Manufacturer

Cordis Corporation

14201 NW 60TH AVE.

MIAMI LAKES

33014

Florida

UNITED STATES