VEIN360
Received Jun 23, 2026 · Event occurred May 27, 2026
Report 3032391-2026-00044 · MDR key 25599155
Device
Generic name
Visions Pv .014p Rx Digital Ivus 150
Manufacturer
Medline RenewalCatalog number
014RRH
Lot number
344471
Product problems
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED "DEVICES FAILED VOLCANO CLEARANCE DUE TO "FAULTY CAMERA" SOFTWARE RECOGNITION ISSUES."
Additional Manufacturer Narrative
IT WAS REPORTED "DEVICES FAILED VOLCANO CLEARANCE DUE TO "FAULTY CAMERA" SOFTWARE RECOGNITION ISSUES." THERE ARE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.