ACIST CVi® Angiographic Injection System Injector Head 014657Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10841716101233), received between Feb 1, 2018 and Jan 6, 2026 — classified as 3 deaths, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathJan 6, 2026Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY ANGIOGRAPHY, AFTER THE USER COMPLETED A FULL FLUSH OF THE CONSUMABLE TUBING AND CATHETER, AND CONFIRMED THAT THE SYSTEM WAS FUNCTIONING PROPERLY, THE FIRST CONTRAST MEDIA INJECTION WAS COMPLETED WITHOUT ANY ISSUES. DURING THE SECOND INJECTION OF CONTRAST MEDIA, APPROXIMATELY 6 CUBIC CENTIMETERS OF AIR WAS INJECTED INTO THE PATIENT. AIR BUBBLES WERE OBSERVED IN THE PATIENT'S LEFT CORONARY SIDE DURING THE INJECTION. THE PATIENT EXPIRED ON (B)(6) 2025.

  Patient problems: Air Embolism

  MAUDE report 23979826 ↗
• MalfunctionSep 30, 2024

  PERSONNEL IN CARDIAC CATHETERIZATION LAB WERE CLEANING ROOM BETWEEN CASES, NOTED A SMELL AND SOME SMOKE AND A SMALL LINE OF "SPARK" AND BURN WITHIN THE WELL OF THE SYRINGE SPACE WAS NOTED. THE DEVICE WAS IMMEDIATELY UNPLUGGED. THE DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332644 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED THAT A (B)(6) MALE WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WAS TAKEN TO THE CATH LAB FOR LEFT HEART CATHETERIZATION (LHC) WITH PERCUTANEOUS CORONARY INTERVENTION (PCI). ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI WAS USED FOR CONTRAST INJECTIONS. UPON THE SIXTH INJECTION OF CONTRAST INTO THE PATIENT, AIR WAS VISIBLE WITHIN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT EXPERIENCED ACUTE CHRONIC CHEST PAIN FOR 1-2 MINUTES POST INJECTION AND BLOOD PRESSURE < 90 MMHG SYSTOLIC. THE PATIENT TOLERATED THE AIR INJECTION WITH NO DETERIORATION IN CLINICAL CONDITION.

  Patient problems: Air Embolism

  MAUDE report 14218923 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE START OF A CORONARY ANGIOGRAPHY PROCEDURE OF A (B)(6)YEAR OLD MALE, IT WAS NOTICED THAT THERE WAS APPROXIMATELY 10 ML OF AIR IN THE RIGHT CORONARY ARTERY (RCA) AND LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT EXPERIENCED CHEST PAIN FOR A DURATION OF TEN MINUTES, ST SEGMENT ELEVATION, BRADYCARDIA, AND BLOOD PRESSURE < 90 MMHG SYSTOLIC. THE PATIENT RECOVERED THE SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 12467162 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ANGIOPLASTY PROCEDURE AT THE SECOND INJECTION DURING FINAL CONTROL, SOME LARGE BUBBLES OF AIR WERE INJECTED INTO A PATIENT. THE PATIENT EXPERIENCED CHEST PAIN AND ST SEGMENT ELEVATION FOR A DURATION OF A FEW MINUTES. THE PATIENT RECOVERED THE SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 12394138 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERCUTANEOUS CORONARY INTERVENTION FOR LEFT ANTERIOR DESCENDING STENOSIS AND USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, THE USER REPORTED THAT JUST AFTER THE CONTRAST INJECTION INTO PATIENT'S LEFT CIRCUMFLEX ARTERY, AIR INFUSION WAS OBSERVED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT'S ECG SHOWED ST SEGMENT DEPRESSION OF UNKNOWN DURATION. THE PATIENT SUBSEQUENTLY DIED ON (B)(6) 2021.

  Patient problems: Air Embolism

  MAUDE report 12245791 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT HEART CATHETERIZATION FOR CHEST PAIN, SLOW FLOW WAS NOTED IN THE LEFT CORONARY SYSTEM AFTER THE FIRST INJECTION. AIR EMBOLUS WAS SUSPECTED BUT NOT VERIFIED. THE PATIENT EXPERIENCED CHEST PAIN FOR A DURATION OF 15 MINUTES, HYPOTENSION AND BRADYCARDIA WITH RESOLUTION BY THE END OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED AND THE PATIENT RECOVERED THE SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 11737670 ↗
• DeathFeb 6, 2018Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED: A (B)(6) FEMALE PATIENT WAS EXPERIENCING UNSTABLE ANGINA AND WAS UNDERGOING A CORONARY ANGIO. A CORONARY DISSECTION OCCURRED AFTER INJECTION INTO THE RIGHT CORONARY ARTERY (RCA). THE PATIENT EXPERIENCED SHOCK, CHEST PAIN, ST-SEGMENT ELEVATION, VENTRICULAR FIBRILLATION, HYPOTENSION, AND MYOCARDIAL INFARCTION. THE PATIENT EXPIRED (B)(6) 2017.

  Patient problems: Death

  MAUDE report 7245334 ↗
• DeathFeb 1, 2018Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STEMI PROCEDURE WAS PERFORMED ON A (B)(6) YEAR OLD MALE PATIENT TRANSFERRED FROM THE EMERGENCY DEPARTMENT. AT THE VERY BEGINNING OF THE PROCEDURE, ERROR MESSAGES APPEARED, "AIR COLUMN DETECTED" AND "TURN OFF STOPCOCK TO THE PATIENT TO PURGE." ONE ENTIRE BOTTLE OF CONTRAST WAS PURGED. A NEW SET UP WAS DRAWN, AND THE SAME ERROR MESSAGES OCCURRED. AFTER THIS, MANUAL INJECTIONS WERE DONE. THE PATIENT EXPERIENCED CHEST PAIN, ABNORMAL HEART RHYTHM (VTACH, VFIB, ASYSTOLE). BLOOD PRESSURE <90 MMHG SYSTOLIC, MYOCARDIAL INFARCTION, AND CARDIAC BIOMARKER ELEVATION, TROP 11.9. THE OUTCOME OF THE EVENT WAS THAT THE PATIENT EXPIRED.

  Patient problems: Death

  MAUDE report 7234496 ↗