ACIST CVi® Contrast Delivery System 014657Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 40841716101876), received between Aug 9, 2019 and Jun 12, 2025 — classified as 2 deaths, 7 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 16, 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.

• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY ANGIOGRAPHIC PROCEDURE, FOR A PATIENT PRESENTING WITH NON-ST-SEGMENT MYOCARDIAL INFARCTION, AIR WAS INJECTED INTO THE PATIENT'S LEFT ANTERIOR DESCENDING ARTERY. PATIENT HAD CARDIAC BIOMARKER ELEVATION. IT IS UNKNOWN IF THIS WAS RELATED TO THE AIR INJECTED OR THE PATIENT'S PRESENTING CONDITION. PATIENT WAS REPORTED AS STABLE.

  Patient problems: Air Embolism

  MAUDE report 22197418 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CARDIAC CATHETERIZATION FOR A PATIENT PRESENTING WITH CHEST PAIN, SIX MINUTES AFTER THE START OF THE PROCEDURE, AIR WAS INJECTED INTO THE PATIENT'S RIGHT CORONARY ARTERY (RCA). THE PATIENT EXPERIENCED HYPOTENSION AND VENTRICULAR FIBRILLATION. THE PATIENT WAS STABLE AFTER DEFIBRILLATION PERFORMED.

  Patient problems: Air Embolism

  MAUDE report 21692376 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RIGHT AND LEFT HEART CATHETERIZATION USING THE ACIST CVI CONTRAST INJECTION SYSTEM, AFTER THE USER PURGED THE CONSUMABLE TUBING OF AIR AND DURING THE FIRST INJECTION, 6 CC OF AIR WAS INJECTED INTO THE PATIENT. THE USER NOTICED AIR BUBBLES IN THE CONSUMABLE TUBING THAT APPEARED TO MOVE BACKWARD AWAY FROM THE PATIENT, TOWARDS THE STOPCOCK. THE PATIENT EXPERIENCED CHEST PAIN, ST SEGMENT ELEVATION FOR A DURATION OF FIVE MINUTES, AND HYPOTENSION. THE PHYSICIAN ADMINISTERED EPINEPHRINE AND FLUSHED . THE INCIDENT RESOLVED QUICKLY, AND THE PATIENT RECOVERED SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 19729844 ↗
• DeathMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED THAT THE PATIENT WAS IN THE CARDIAC CATH LAB FOR AN OUT PATIENT LEFT HEART CATH PROCEDURE. FEMORAL ACCESS OBTAINED BY PROVIDER WITH 5FR SHEATH WITHOUT COMPLICATIONS. LEFT MAIN SELECTIVELY ENGAGED. A TEST INJECTION OF APPROXIMATELY 2ML - 3ML OF CONTRAST WAS COMPLETED, AND DURING THIS TEST INJECTION, THERE WAS A SLUGGISH FLOW IN BOTH THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND CIRCUMFLEX ARTERIES. THE PATIENT STARTED EXPERIENCING CHEST PAIN IMMEDIATELY AFTER THE FIRST INJECTION, ST ELEVATION, BRADYCARDIA/ASYSTOLE, AND HYPOTENSION. CODE BLUE WAS CALLED. THE PATIENT EXPIRED AFTER MUCH EFFORTS TO RESUSCITATE. UNKNOWN CAUSE FOR DETERIORATION IN PATIENT'S CONDITION. NOTE: THE PERSON REPORTING THE COMPLAINT STATED THAT THERE WERE NO AIR COLUMN DETECTED MESSAGE DISPLAYED BY THE CVI INJECTION SYSTEM AND NO AIR EMBOLUS REPORTED.

  Patient problems: Air Embolism

  MAUDE report 18991729 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEFT VENTRICLE (LV) ANGIOGRAM WAS PERFORMED FOR VENTRICULAR SEPTAL DEFECT (VSD) WITH NO ISSUE, USING THE ACIST CVI INJECTION SYSTEM (SYSTEM SETTINGS OF 12ML, 18ML/SEC, 0 RISE, 1200 PSI). THE CVI CONSUMABLE TUBING WAS CONNECTED TO PIGTAIL CATHETER TO PERFORM THE LV ANGIOGRAM. AN "AIR COLUMN DETECTED" MESSAGE DISPLAYED ON THE CVI INJECTOR SYSTEM'S CONTROL PANEL DISPLAY. THE USER DISCONNECTED THE CVI CONSUMABLE TUBING FROM THE CATHETER, AND PURGED CONTRAST THROUGH THE TUBING TO CLEAR THE AIR. THE "AIR COLUMN DETECTED" MESSAGE CLEARED, AND THE CVI CONSUMABLE TUBING WAS RECONNECTED TO A PIGTAIL CATHETER. AN LV ANGIO WAS PERFORMED USING CVI INJECTOR SYSTEM SETTINGS 12ML, 18ML/SEC, 1200 PSI, 0.5SEC RISE. DURING THE LV ANGIO, AN ST-SEGMENT ELEVATION WAS NOTED AND AN AIR EMBOLUS WAS OBSERVED IN THE PATIENT'S RIGHT CORONARY ARTERY (RCA) AND AORTA (AO). THE PATIENT BECAME HYPOTENSIVE AND THE PATIENT'S FRACTION OF INSPIRED OXYGEN (FIO2) INCREASED TO 100%. PHENYLEPHRINE WAS ADMINISTERED TO THE PATIENT TO TREAT HYPOTENSION. PATIENT'S EKG RETURNED TO BASELINE AFTER 5-10 MINUTES. UPON DISCONNECTING THE CVI CONSUMABLE TUBING FROM THE CATHETER, IT WAS NOTED TO NOT BE MAINTAINING FORWARD PRESSURE,

  Patient problems: Air Embolism

  MAUDE report 17406348 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT HEART CATHETERIZATION (LAD) FOR CORONARY ARTERY DISEASE (CAD) ON A 73-YEAR-OLD FEMALE PATIENT, AIR BUBBLES WERE INJECTED INTO THE PATIENT'S RIGHT CORONARY ARTERY (RCA); COLUMN OF AIR WITH NO FLOW PAST THE PROXIMAL SEGMENT. PATIENT EXPERIENCED BLOOD PRESSURE OF LESS THAN < 90 MMHG SYSTOLIC, ST-SEGMENT ELEVATION ON THE EKG, HYPOXIA, AND CHEST PAIN. THE PATIENT WAS ADMINISTERED HEPARIN, NEOSYNEPHRINE / LEVOPHED, AND PLACED ON OXYGEN. GUIDEWIRE INTRODUCED TO RCA, PRONTO THROMBECTOMY CATH PERFORMED, AND PATIENT WAS GIVEN A DOSE OF NITROGLYCERIN AND INTRACORONARY ADENOSINE. THE REPEAT ANGIOGRAM SHOWED RESTORATION OF FLOW AND THE PATIENT'S SYMPTOMS SUBSIDED. THE PATIENT SUBSEQUENTLY RECOVERED.

  Patient problems: Air Embolism

  MAUDE report 16743005 ↗
• DeathSep 10, 2020Gas/Air Leak

  DURING A CATHETERIZATION PROCEDURE, AIR WAS INJECTED INTO A PATIENT. THE USER REPORTED THAT THE TRANSDUCER WAS NOT PROVIDING A PRESSURE WAVEFORM; THE USER REPLACED THE TRANSDUCER. THE USER REPEATED THE SETUP OF THE CONSUMABLE KITS WITH THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI. AT THE START OF THE PROCEDURE, UPON THE FIRST INJECTION OF CONTRAST, THE USER OBSERVED A SMALL AMOUNT OF AIR. POST THE AIR INJECTION, THE PATIENT EXPIRED.

  Patient problems: Air Embolism

  MAUDE report 10517921 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED, DURING A DIAGNOSTIC LEFT HEART AND LIMA GRAFT CATHETERIZATION ON A PATIENT WITH ANGINA, AND PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI), THE USER PUT A 6 FR IM CATHETER INTO THE PATIENT'S LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT OF THE OSTIUM AND THE CATHETER DISSECTED THE LIMA GRAFT. THE PATIENT EXPERIENCED ST-SEGMENT ELEVATION, ABNORMAL HEART RHYTHM, AND HYPOTENSION. THE USER OBSERVED THE DISSECTION ON THE IMAGES. THE PCI WAS ABORTED AND A BALLOON PUMP WAS INSERTED TO STABILIZE THE PATIENT. THE USER BELIEVES THE DISSECTION WAS RELATED TO THE NON-ACIST CATHETER. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 9802612 ↗
• InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE DIAGNOSTIC PORTION OF A COMBINATION DIAGNOSTIC/INTERVENTIONAL PROCEDURE USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, AN UNKNOWN AMOUNT OF AIR WAS INJECTED INTO THE PATIENT DURING A SECOND INJECTION INTO THE LEFT CORONARY ARTERY (LCA). THE PATIENT EXPERIENCED BLOOD FLOW RESTRICTION, HYPOTENSION, AND ST-SEGMENT ELEVATION. THE PATIENT WAS ADMINISTERED SALINE TO TREAT THE HYPOTENSION.

  Patient problems: Air Embolism

  MAUDE report 8880092 ↗