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