ACIST CVi® Angiographic Injection System 014657Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 40841716101418), received between Feb 9, 2018 and Jul 24, 2025 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT HEART CATHETERIZATION FOR CARDIOMYOPATHY AND ACUTE HEART FAILURE, AIR WAS INJECTED INTO A PATIENT. FOLLOWING RADIAL SHEATH PREP FOR SPASM PROPHYLAXIS, A 5 FRENCH JL3.5 CATHETER WAS TAKEN OVER A J-WIRE AND USED TO ENGAGE THE LEFT MAIN OSTIUM FOR LEFT CORONARY ANGIOGRAPHY. THE CATHETER WAS FLUSHED TWICE PER STANDARD PROCESS USING 10CC SYRINGES; THERE WAS NO AIR ALERT MESSAGE DISPLAYED BY THE CVI INJECTION SYSTEM. A SUBSEQUENT TEST INJECTION WAS COMPLETED TO CONFIRM ENGAGEMENT OF THE LEFT MAIN. THERE WAS SIGNIFICANT AIR EMBOLISM INTO THE CIRCUMFLEX AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD), ALONG THE MID CIRCUMFLEX AND MID LAD WITH NO FLOW IN THE DISTAL VESSELS SEEN. AN INITIAL QUICK ATTEMPT TO ASPIRATE THROUGH THE JL 3.5 DIAGNOSTIC CATHETER WAS UNSUCCESSFUL. THE PATIENT QUICKLY DETERIORATED, BECAME BRADYCARDIC, AND WAS GIVEN 1 MG OF ATROPINE. THE PATIENT BECAME UNRESPONSIVE AND AN EMERGENT AIRWAY WAS CALLED; HE WAS INTUBATED. THE PATIENT SUBSEQUENTLY WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. AFTER ONE ROUND OF CPR AND 1 MG OF EPINEPHRINE (EPI), THERE WAS RETURN OF SPONTANEOUS CIRCULATION (ROSC). THE U

  Patient problems: Air Embolism

  MAUDE report 22588983 ↗
• InjuryJan 29, 2020Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER INJECTING INTO THE LEFT VENTRICLE DURING A LEFT VENTRICLE CATHETERIZATION PROCEDURE, THE PHYSICIAN RINSED THE HIGH PRESSURE TUBING WITH SALINE TO PERFORM PRESSURE MEASUREMENTS IN THE LEFT VENTRICLE AND NOTED BUBBLES IN THE HIGH PRESSURE TUBING. THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) DURING THE PROCEDURE. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND THE RESULTS CONFIRMED NO AIR WAS PRESENT IN THE PATIENT'S BRAIN. THE USER FACILITY NOTES THEY DID NOT CONFIRM AIR WAS INJECTED INTO THE PATIENT DURING THE CATHETERIZATION PROCEDURE.

  Patient problems: Air Embolism

  MAUDE report 9645407 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem

  DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE RIGHT CORONARY ARTERY (RCA), THE PATIENT'S RCA AND AORTA WERE DISSECTED. THE PATIENT WAS TAKEN TO EMERGENCY SURGERY AND A SAPHENOUS VEIN GRAFT TO THE RCA WAS COMPLETED AND THE AORTA WAS REPAIRED.

  Patient problems: Aortic Dissection; Vascular Dissection

  MAUDE report 8634899 ↗
• InjuryFeb 9, 2018Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED: A MALE PATIENT, AGE (B)(6) YEARS, UNDERGOING A CORONARY ANGIO FOR A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI), HAD A CORONARY DISSECTION DURING A CORONARY ANGIO. THERE WERE NO CLINICAL SYMPTOMS. THE EVENT RESULTED IN PROLONGATION OF HOSPITALIZATION. THE PATIENT RECOVERED. RECOVERY DATE WAS NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 7261507 ↗
• InjuryFeb 9, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED: A FEMALE PATIENT, AGE (B)(6), UNDERGOING A CORONARY ANGIO FOR A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI), HAD A CORONARY DISSECTION FOLLOWING CORONARY ANGIO. DISSECTION OCCURRED AFTER THE SECOND INJECTION INTO THE RIGHT CORONARY ARTERY (RCA). PATIENT EXPERIENCED CHEST PAIN OF LESS THAN ONE HOUR IN DURATION, ST-SEGMENT ELEVATION, AND EVIDENCE OF MYOCARDIAL INFARCTION. THE PATIENT RECOVERED. RECOVERY DATE WAS NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 7261503 ↗