MYNX CONTROL VENOUS
Received Jul 20, 2026
Report 3004939290-2026-00939 · MDR key 25868254
Device
Generic name
Device, Hemostasis, Vascular
Manufacturer
Cordis Us Corp.Model number
NACatalog number
MX61260
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
Narrative
Description of Event or Problem
AS REPORTED, THREE 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (VCD) WERE ASSOCIATED WITH GROIN ISSUES WITH POSSIBLE INFECTIONS. THE PATIENT REPORTEDLY HAD GROIN SITES THAT WERE DRAINING PUS. THE PATIENT DID NOT RETURN FOR EVALUATION. THE SITES WERE NOT CULTURED, AND THE PHYSICIAN PLACED THE PATIENTS ON ANTIBIOTICS. THERE WAS NO REPORTED PATIENT INJURY. IT WAS REPORTED THAT THE PATIENTS ALL HAD 3 ACCESS SITES THAT WERE ALL CLOSED WITH MYNX VENOUS ON THE RIGHT GROIN. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.