UL_INJECT XD 8000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052536002245), received between May 2, 2025 and May 2, 2025 — classified as 1 death.

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. How this data works · Data updated Oct 13, 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.

• DeathMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO USER INFORMATION: "ON (B)(6) 2025 AT 11:45 A.M., MS. (B)(6) REPORTED THE DEATH OF A PATIENT DUE TO AIR IN THE HEART IN RELATION TO (B)(6). A CT THORAX ABDOMEN EXAMINATION WITH ULTRAVIST 300 IN 500 ML GLASS BOTTLES AT A FLOW RATE OF 3ML/S WITH 21ML NACL / 100ML KM / 30ML NACL. THE CONTRAST AGENT WAS NOT PREHEATED. A 320 CM PATIENT TUBE WAS USED. ACCESS WAS VIA A PORT SYSTEM THAT IS ALSO USED FOR CHEMOTHERAPY. MS. (B)(6) WAS UNABLE TO STATE THE AMOUNT OF AIR. THE INJECTOR DID NOT SHOW ANY ERROR MESSAGES."

  Patient problems: Cardiac Arrest

  MAUDE report 21948403 ↗