Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

FDA Recall Z-0720-2023 · Posted 2022-12-16

Recalling FirmCordis US Corp
Recall StatusOpen, Classified
Product CodeDQO
Date Initiated2022-11-07
Product Quantity16,950 units (2,915 US and 14,000 OUS)

Reason for Recall

There is a potential for separation at the male connector.

Firm Action

Cordis notified consignees on approximately 11/07/2022 via letter titled "Urgent MEDICAL DEVICE RECALL" sent to the Materials Director and Risk Manager. The letter instructed consignees to identify and segregate any affected product on hand, complete and return the Acknowledgement Form by email: [email protected], and return all affected product. Additionally, customers were instructed to share the letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units. OUS consignee notification will be conducted by Cordis affiliates in the affected countries / regions. For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 1, Monday through Friday from 9:00 AM to 5:00 PM EDT. For questions related to assistance returning product or billing concerns please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00 AM to 8:00 PM EDT. For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact Cordis QA at: [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV, WY and PR. International distribution to Japan, Korea, Republic of, United Arab Emirates, Austria, Belgium, Czech Republic, Germany, Spain, France, United Kingdom, Iceland, Ireland, Israel, Netherlands, Portugal, Russia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑