RITA 700102623Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H7877001026230), received between Jul 25, 2018 and Jul 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• MalfunctionJul 25, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: ANGIODYNAMICS' DISTRIBUTOR REPORTED WHEN DOING AN IN-HOUSE WAREHOUSE INSPECTION OF INCOMING DEVICES, WHEN OPENING THE SHIPPING BOX, THE INTERNAL PACKAGES WERE DAMAGED, SOME EXHIBITED PUNCTURES AND SCRAPE MARKS, AND ONE CONTAINED A TORN SEAL. THE DAMAGE TO THE PACKAGES COMPROMISED THE STERILITY OF THE MEDICAL DEVICES. AS THE DAMAGE WAS NOTED AT THE DISTRIBUTOR'S INSPECTION PROCESS, THERE WAS NO PATIENT INVOLVEMENT. THE DAMAGED PACKAGES HAVE BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7719466 ↗