EmpowerCTA®+ Injector System 017285 (UDI 47630039300904)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 47630039300904), received between Nov 15, 2022 and Dec 28, 2023 — classified as 2 deaths, 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2023, (B)(4) BECAME AWARE THAT AFTER A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND PELVIS WITH AN EMPOWERCTA+ INJECTION SYSTEM, SERIAL NUMBER (B)(6), THE TECHNOLOGIST NOTICED AN UNKNOWN AMOUNT OF ISOVUE 300 CONTRAST ON THE FLOOR FROM A LEAKING CONNECTION BETWEEN THE INJECTOR TUBING AND THE INTRAVENOUS (IV) LINE. AN UNKNOWN AMOUNT OF AIR WAS LATER OBSERVED IN THE IMAGING IN THE PATIENT'S LEFT VENTRICLE. ON (B)(6) 2023, (B)(4) BECAME AWARE THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL DUE TO THE VISUALIZATION OF AIR ON THE CT IMAGES. THE PATIENT WAS REPORTED TO HAVE RECOVERED ON (B)(6) 2023.

  Patient problems: Air Embolism

  MAUDE report 18414463 ↗
• DeathJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A COMPUTED TOMOGRAPHY (CT) SCAN OF THE CHEST FOR PULMONARY EMBOLISM, APPROXIMATELY 30 CC OF AIR WAS INJECTED INTO THE PATIENT. THE PATIENT EXPERIENCED NAUSEA, VOMITING, CHEST PAIN, BRADYCARDIA, AND A DECLINE IN MENTAL STATUS. AN ECHOCARDIOGRAM (ECG) REVEALED ELEVATED ST SEGMENTS AND THE PATIENT'S BLOOD PRESSURE READINGS WERE AS FOLLOWS: 64/221, 45/121, AND 123/74. THERE WAS EVIDENCE OF MYOCARDIAL INFARCTION, SPECIFICALLY CARDIAC BIOMARKER ELEVATION. THE AIR INJECTION WAS FIRST NOTICED THIRTY (30) MINUTES AFTER THE EXAM WAS COMPLETED. THE PATIENT EXPIRED ON (B)(6) 2022.

  Patient problems: Air Embolism

  MAUDE report 16178260 ↗
• DeathNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A COMPUTED TOMOGRAPHY (CT) SCAN OF THE CHEST FOR PULMONARY EMBOLISM, APPROXIMATELY 30 CC OF AIR WAS INJECTED INTO THE PATIENT. THE PATIENT EXPERIENCED NAUSEA, VOMITING, CHEST PAIN, BRADYCARDIA, AND A DECLINE IN MENTAL STATUS. AN ECHOCARDIOGRAM (ECG) REVEALED ELEVATED ST SEGMENTS AND THE PATIENT'S BLOOD PRESSURE READINGS WERE AS FOLLOWS: 64/221, 45/121, AND 123/74. THERE WAS EVIDENCE OF MYOCARDIAL INFARCTION, SPECIFICALLY CARDIAC BIOMARKER ELEVATION. THE AIR INJECTION WAS FIRST NOTICED THIRTY (30) MINUTES AFTER THE EXAM WAS COMPLETED. THE PATIENT EXPIRED ON (B)(6) 2022.

  Patient problems: Air Embolism

  MAUDE report 15798223 ↗