December 7, 2023 — The U.S. Food and Drug Administration (FDA) announced Cordis US Corp is recalling its INFINITI Angiographic Catheter due to products being shipped without undergoing sterilization procedures. 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.
- Product Names: Cordis INFINITI Angiographic Catheter
- Product Codes: DQO
- Lot Number: 18223410
- Distribution Dates: August 21, 2023 to September 25, 2023
- Devices Recalled in the U.S.: 30 (3 X 10-pack boxes)
- Date Initiated by Firm: September 26, 2023
The Cordis INFINITI Angiographic Catheter delivers contrast dye to specific places in the blood vessels. It helps doctors see the blood vessels in the brain, organs, or limbs during certain procedures. The catheter is put into the body through the skin and can be used in multiple places at once.
Reason for Recall
Cordis US Corp is recalling INFINITI Angiographic Catheter due to some of the products being shipped to end users without undergoing sterilization procedures. The INFINITI Angiographic Catheter is intended to be shipped sterile directly from the manufacturer to a third-party distributor, which in turn ships the product to end users such as hospitals.
Lot 18223410 was distributed without being properly sterilized. All units, except 3 boxes (30 units of the 500 units in the lot), were sent back to the manufacturer in Mexico. A review of shipments revealed that these 30 units had been shipped to a single facility. Cordis US Corp also phoned the sole consignee on September 26, 2023 to notify them of this issue. Cordis US Corp then issued an Urgent Medical Device Recall Notice to its sole consignee on September 28, 2023 to request the return of all affected product.
The use of unsterilized angiographic catheters may result in serious acquired infections, sepsis, and in extreme cases, death.
There have been no reports of death or injury associated with this issue.
Who May be Affected
- Medical professionals, particularly interventional radiologists or cardiologists, who use the Cordis INFINITI Angiographic Catheter during procedures like angiographies.
- People who are going through procedures like angiographies
What to Do
On September 28, 2023, Cordis US Corp sent the sole consignee an Urgent Medical Device Recall Notice.
The letter requested customers to:
- Immediately check inventory to confirm that no units from the affected lots are in their possession. Identify and set aside any units from the identified lots in a manner that ensures the affected product will not be used.
- Review, complete, sign and return the Acknowledgement Form directly to Cordis by email to: [email protected]
- Return any affected product.
- Share this letter with others in their facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from their facility.
- If any units of the affected lots are found to be at the other facility, please arrange the return of the units.
Customers in the U.S. with questions about this recall should contact Cordis QA at: [email protected] or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.
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.