ACIST CVi® Contrast Delivery System 014658Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 40841716101883), received between Mar 1, 2022 and Mar 13, 2025 — classified as 3 injuries.

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.

• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ANGIOGRAPHY USING THE ACIST INJECTION SYSTEM, MODEL CVI, UPON THE FIRST INJECTION OF CONTRAST MEDIA INTO THE LEFT CORONARY ARTERY, APPROXIMATELY 5CC OF AIR WAS INJECTED INTO THE PATIENT'S ARTERY. THE PATIENT EXPERIENCED ST SEGMENT ELEVATION FOR A DURATION OF 47 SECONDS AND THE PATIENT'S HEART RATE DECREASED. THE PATIENT RECOVERED THE SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 21594170 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY ANGIOGRAPHY, A PATIENT WAS INJECTED WITH CONTRAST SUCCESSFULLY. NO MALFUNCTIONS OR ERRORS OCCURRED, AND NO AIR WAS DETECTED IN THE PATIENT TUBING DURING THE INJECTION. WHEN VIEWING THE IMAGE, AN AIR EMBOLUS WAS SEEN IN THE PATIENT'S ARTERY. THE PATIENT RETURNED TO THE USER FACILITY THE FOLLOWING DAY AFTER HAVING A STROKE.

  Patient problems: Air Embolism

  MAUDE report 18060661 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE FIRST INJECTION OF CONTRAST INTO THE PATIENT DURING A CARDIAC ANGIOGRAM FOR UNSTABLE ANGINA, THE PHYSICIAN NOTICED THAT SOMETHING LOOKED OFF IN THE IMAGES. ON THE SECOND INJECTION OF CONTRAST INTO THE PATIENT, THE PATIENT'S BLOOD PRESSURE DROPPED TO 60 MMHG SYSTOLIC AND EKG CHANGES WERE NOTED. THE PATIENT DID NOT COMPLAIN OF ANY PAIN, BUT THE PATIENT WAS ALSO SEDATED DURING THE PROCEDURE. THE PHYSICIAN WAS CONCERNED AT THIS TIME THAT THE PATIENT'S VESSELS WERE SPASMING OR THERE WAS A SUSPECTED AIR BUBBLE IN THE VESSEL. AFTER REVIEWING THE IMAGES, THE PHYSICIAN SAW WHAT APPEARED TO BE BUBBLES GOING DOWN THE LEFT ANTERIOR DESCENDING AND LEFT CIRCUMFLEX ARTERIES. THERE WERE NO BUBBLES SEEN ON REPEAT IMAGES TAKEN OF THE LEFT CORONARY SYSTEM. THE PATIENT'S CONDITION STARTED TO IMPROVE WITHIN TEN MINUTES OF THE INITIAL CONTRAST INJECTIONS. NO INTERVENTIONS WERE NEEDED TO SUPPORT THE PATIENT DURING THIS EVENT, AND THE PATIENT RECOVERED THE SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 13638809 ↗