ACIST CVi® Contrast Delivery System Injector Head 016224Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10841716101875), received between Aug 28, 2020 and Aug 19, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT HEART CATHETERIZATION (LHC) USING THE ACIST CVI CONTRAST INJECTION SYSTEM, THE RIGHT CORONARY ARTERY (RCA) WAS INJECTED WITH CONTRAST THAT SHOWED STENOSIS. SUBSEQUENT INJECTION OF CONTRAST WAS FOLLOWED BY AIR BUBBLES, CAUSING THE PATIENT TO BECOME UNRESPONSIVE. THE PATIENT HAD UNEQUAL PUPILS AND RIGHT-SIDE FLACCIDITY. A STROKE ALERT WAS CALLED WITH A CT SCAN OF THE HEAD PERFORMED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND THEN TO THE UNIVERSITY OF KENTUCKY HOSPITAL. THE PATIENT RECOVERED AFTER TRANSPORT.

  Patient problems: Air Embolism

  MAUDE report 22840221 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY ANGIOGRAPHY, A STUDENT DOCTOR INJECTED AIR INTO THE PATIENT UPON THE LAST INJECTION OF CONTRAST MEDIA. THE PATIENT FLATLINED FOR 30 SECONDS, AFTER WHICH THE PATIENT BECAME RESPONSIVE AND WAS AWARE. ACCORDING TO THE USER FACILITY, THE AIR INJECTION WAS DUE TO USER ERROR. THE USER FACILITY REPORTED THAT THEY HAVE A CINE-ANGIOGRAM OF THE PROCEDURE THEY WILL EMAIL TO ACIST.

  Patient problems: Air Embolism

  MAUDE report 22512245 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER REPORTED WHEN FINISHING THE CASE, UPON REVIEW OF THE IMAGES, A LARGE AMOUNT OF AIR WAS OBSERVED. THE PATIENT CODED AND WAS REVIVED. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED.

  Patient problems: Air Embolism

  MAUDE report 18209037 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT AND LEFT HEART CATHERIZATION PROCEDURE TO RULE OUT VALVULAR AND CORONARY ARTERY DISEASE, UPON INJECTION OF THE RIGHT CORONARY ARTERY, AIR WAS INJECTED INTO THE PATIENT. THE PATIENT EXPERIENCED ST SEGMENT ELEVATION AND WAS PUT ON 100% OXYGEN. THE CATH LAB STAFF BELIEVE THEY DIDN'T CLEAR THE STOP COCK BEFORE CATHETER EXCHANGE. THE PATIENT RECOVERED THE SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 13286090 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER 40 MINUTES IN TO A LEFT HEART CATHETER CORONARY INTERVENTION, SMALL AIR BUBBLES (APPROXIMATELY 3CC) WERE INJECTED INTO A PATIENT. THE PATIENT EXPERIENCED BLOOD PRESSURE <90 MMHG SYSTOLIC. THE PATIENT RECOVERED THE SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 12628981 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AND AFTER A GUIDING CATHETER REPLACEMENT, A COUPLE OF CC'S OF AIR WAS INJECTED INTO THE PATIENT. THE DOCTOR WAS USING A TELEFLEX Y CONNECTOR AND FORGOT TO BLEED BACK THE Y CONNECTOR. THE ECG SHOWED ELEVATED ST SEGMENT CHANGES AND THE PATIENT RECOVERED THE SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 12583796 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERCUTANEOUS CORONARY INTERVENTION FOR A STRESS TEST, AN AIR BUBBLE WAS INJECTED FOLLOWING THE BALLOON REMOVAL. THE PATIENT EXPERIENCED CHEST PAIN FOR A DURATION OF FIVE MINUTES AND ST SEGMENT ELEVATION FOR A DURATION OF APPROXIMATELY THREE MINUTES. THE PATIENT RECOVERED ON (B)(6) 2021.

  Patient problems: Air Embolism

  MAUDE report 12344750 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED THAT DURING A LEFT HEART CATHETERIZATION AND CORONARY INTERVENTION FOR A PATIENT WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI), ON THE FIRST FULL INJECTION OF CONTRAST USING A LEFT GUIDE CATHETER WITH TUOHY AND THE ACIST CONTRAST INJECTION SYSTEM, MODEL CVI, AIR WAS INJECTED INTO THE PATIENT'S LEFT CORONARY SYSTEM. PRIOR TO THE FIRST FULL INJECTION, THE LEVEL OF CONTRAST MEDIA WITHIN THE SYRINGE IN THE CVI INJECTION SYSTEM WAS LOW. THE USER TRIED DO A REFILL FROM THE CVI INJECTION SYSTEM CONTROL PANEL SCREEN, AND THE INJECTOR WOULD ONLY FILL A FEW CCS OF CONTRAST INTO THE SYRINGE AT A TIME. THE USERS FOUND THAT THE CONTRAST SENSOR WAS COVERED IN DRIED CONTRAST MEDIA. THE USERS CLEANED THE CONTRAST SENSOR WITH WARM WATER. THE HIGH-PRESSURE TUBING, STOPCOCK, AND CATHETER WERE PROPERLY FLUSHED AND PURGED WITH CONTRAST. IT WAS NOTED THAT THERE WAS BLOOD THAT HAD FLOWED BACK INTO THE CATHETER AND TUOHY. THE LEFT MAIN ARTERY WAS DIFFICULT TO ENGAGE, AND SEVERAL TEST INJECTIONS OF CONTRAST WERE PERFORMED. UPON THE FIRST FULL INJECTION OF CONTRAST MEDIA, AIR BUBBLE/S WERE SEEN IN THE LEFT CORONARY SYSTEM; THE AIR WENT DOWN ALL VESSELS OF THE LEFT CORON

  Patient problems: Air Embolism

  MAUDE report 11638042 ↗
• InjuryAug 28, 2020Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CARDIAC CATHETERIZATION USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, AT INITIAL INJECTION/INITIAL PICTURE AND AFTER USUAL ASPIRATION OF BLOOD FROM THE CATHETER AND FLUSHING OF THE CATHETER, APPROXIMATELY 5-10 ML OF AIR WAS INJECTED INTO THE PATIENT. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND CODE WAS CALLED. INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED INTO THE PATIENT AND PRESSORS ADMINISTERED. THE PATIENT WAS PROVIDED VENTILATOR SUPPORT AND TRANSFERRED TO THE ICU. THE PATIENT RECOVERED (B)(6) 2020.

  Patient problems: Air Embolism; Ventricular Fibrillation

  MAUDE report 10466181 ↗