The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands
- Lot Numbers: See Database Entry
- Distribution Dates: January 1, 2019 to July 20, 2021
- Devices Recalled in the U.S.: 25,000 units
- Date Initiated by Firm: May 19, 2021
Device Use
The Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands is a catheter used to visualize and measure parts of the vascular system when used with radiopaque (X-ray detectable) contrast media.
Reason for Recall
Cordis Corporation is recalling the Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands due to the potential for the marker bands to move or dislodge during procedures. This can happen during procedures where the catheter is trapped between another device and the vessel wall. If this happens this could cause serious adverse events including delays in the procedure, the need for added medical procedures, heart attack, or stroke.
There have been 167 complaints, 8 injuries, and no deaths reported for this issue.
Who May be Affected
- Health care providers using the affected Cordis device
- Patients who have had procedures that used the affected Cordis device
What to Do
On July 20, 2021, Cordis Corporation issued an “Urgent Medical Device Field Correction” letter to all customers with the following instructions:
- Read the “Description” and “Recommendations” sections of the Urgent Medical Device Field Correction letter carefully.
- Sign and return the Acknowledgement Form enclosed in the Urgent Medical Device Field Correction letter directly to Cordis at the fax number on the form or email to: GMB-CordisFieldAction@cardinalhealth.com.
- Share this notification with anyone in the facility that needs to be informed.
- Contact any other facilities that have been provided with units of affected lots.
- Maintain awareness of this communication until the information has been incorporated into the SUPER TORQUE MB Angiographic Catheter labeling.
Contact Information
Customers with questions about this recall should contact Cordis Quality Assurance by emailing GMB-CordisFieldAction@cardinalhealth.com or calling 1-800-327-7714 (Option 1), Monday through Friday from 9:00 AM to 5:00 PM EDT.
Additional Resources:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
