Novaplus® V704-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160001363), received between Aug 1, 2024 and Aug 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2024Product Quality Problem; Product Quality Problem

  INCIDENT WAS DISCOVERED DURING CARDIAC CATHETERIZATION. A LARGE BLUE FIBER WAS FOUND WRAPPED AROUND BURR TIP. THIS WAS DETECTED AFTER EQUIPMENT WAS USED ON PATIENT. TOWELS WERE PLACED OVER THE EQUIPMENT WHILE NOT IN USE. SYRINGES THAT WERE PLACED ON TOP OF THE TOWELS, HAD BLUE FIBERS ON THEIR OUTSIDE. THE SYRINGES WERE PLACED IN CLEAN WATER BOWL TO REFILL THEM, THIS RESULTED IN BLUE FIBERS OBSERVED IN THE CLEAN BOWL. NO PATIENT INJURY OR MEDICAL TREATMENT WAS REQUIRED AS A RESULT OF THE REPORTED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19888329 ↗