Vistec 7320 (UDI 20192253047308)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20192253047308), received between Oct 9, 2024 and Oct 9, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT USED SPONGES WERE THROWN ON TO THE DROP ZONE. THE CIRCULATOR NOTICED WHEN HANGING THEM INTO THE COUNTER BAG, THAT ONE WAS MISSING THE BLUE X RAY STRING. THE AREAS WERE SEARCHED, AND THE CIRCULATOR FOUND THE STRING ON THE FLOOR NEAR THE DROP ZONE. MORE SPONGES WERE EXAMINED AND WERE FOUND TO HAVE THE BLUE DETECTABLE STRING FALLING OUT. ANOTHER SET WAS OPENED WITH THE SAME ISSUE. THE STRING CAN BE EASILY PULLED OUT, THEY COULD BE POTENTIALLY LEFT IN A PATIENT IF THE STRING WOULD BE SEPARATED. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION WAS PERFORMED. IT WAS NOTICED WHEN THE SPONGES WERE REMOVED FROM THE BODY AND THROWN ON TO THE DROP ZONE. ALL SPONGES WERE ACCOUNTED FOR AND REMOVED FROM USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406881 ↗
• MalfunctionOct 9, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT USED SPONGES WERE THROWN ON TO THE DROP ZONE. THE CIRCULATOR NOTICED WHEN HANGING THEM INTO THE COUNTER BAG, THAT ONE WAS MISSING THE BLUE X RAY STRING. THE AREAS WERE SEARCHED, AND THE CIRCULATOR FOUND THE STRING ON THE FLOOR NEAR THE DROP ZONE. MORE SPONGES WERE EXAMINED AND WERE FOUND TO HAVE THE BLUE DETECTABLE STRING FALLING OUT. ANOTHER SET WAS OPENED WITH THE SAME ISSUE. THE STRING CAN BE EASILY PULLED OUT, THEY COULD BE POTENTIALLY LEFT IN A PATIENT IF THE STRING WOULD BE SEPARATED. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION WAS PERFORMED. IT WAS NOTICED WHEN THE SPONGES WERE REMOVED FROM THE BODY AND THROWN ON TO THE DROP ZONE. ALL SPONGES WERE ACCOUNTED FOR AND REMOVED FROM USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406875 ↗