ACIST CVi® Angiographic Injection System 014658Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 40841716101425), received between Feb 24, 2018 and Jan 21, 2025 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathJan 21, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DURING A PERCUTANEOUS CORONARY INTERVENTION USING THE ACIST CVI INJECTION SYSTEM, AIR WAS INJECTED INTO A PATIENT. THE AIR INJECTION OCCURRED AFTER INSERTION OF A CORONARY GUIDING CATHETER AND ENGAGEMENT INTO THE LEFT MAIN CORONARY ARTERY AND UPON INJECTION OF CONTRAST MEDIA. THE PATIENT EXPERIENCED CARDIOGENIC CRASH AND SHOCK AND EXPIRED THE SAME DAY.

  Patient problems: Air Embolism

  MAUDE report 21203140 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AIR WAS INJECTED INTO A PATIENT DURING AN ANGIOGRAPHY. THE PATIENT WAS REVIVED AND WAS REPORTED TO HAVE RECOVERED AFTER THE AIR INJECTION.

  Patient problems: Air Embolism

  MAUDE report 20922050 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PLANNED ELECTROPHYSIOLOGICAL EXAMINATION WITH ABLATION OF THE PULMONARY VEINS, WHEN USING SALINE TO FLUSH THE ACIST CONSUMABLE KITS ATTACHED TO THE ACIST INJECTION SYSTEM, MODEL CVI, THERE WERE REPEATED MASSIVE AIR BUBBLES IN THE CONSUMABLE TUBING. THE USER RESOLVED THE ERROR BY CHANGING THE DELTAMEDICA SALINE INFUSION CONTAINER CONNECTED TO THE CVI CONSUMABLE KIT WITH ANOTHER MANUFACTURER'S SALINE CONTAINER (BRAUN). THE PROCESS OF CHANGING THE SALINE BAG RESULTED IN AN AIR BEING INJECTED INTO THE PATIENT'S CORONARY ARTERIES. THE PATIENT REQUIRED RESUSCITATION. THE USER NOTICED THAT THE WALLS OF THE DELTAMEDICA GMBH, SALINE CONTAINER ARE HARDER THAN THOSE OF THE BRAUN SALINE CONTAINER. EMPTYING THE BOTTLE COULD RESULT IN THE FORMATION OF NEGATIVE INTERNAL PRESSURE WITH A SUBSEQUENT SUCTION EFFECT. ADDITIONALLY, THE RUBBER PLUG IS HARDER THAN THAT THE BRAUN CONTAINER AND IT REQUIRES SIGNIFICANTLY MORE FORCE TO BE PIERCED WITH THE INFUSION CANNULA. THE HARDNESS OF THE RUBBER CAN LEAD TO INADEQUATE SEALING. THE DELTAMEDICA ISOTONIC SODIUM CHLORIDE SOLUTION, 0.9% PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY ACIST. IT IS MANUFACTURED BY DELTAMEDIA GMBH.

  Patient problems: Air Embolism

  MAUDE report 20848139 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED: DURING A PROCEDURE USING THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, AIR WAS INJECTED INTO A PATIENT'S RIGHT CORONARY ARTERY (RCA). THE AIR BUBBLE WAS VISIBLE IN THE RCA. SUBSEQUENTLY, THE PHYSICIAN FLUSHED WITH SALINE AND THE RCA WAS COMPLETELY FREE OF FLOW. THE PATIENT EXPERIENCED ST-SEGMENT ELEVATION AND HYPOTENSION. THE PHYSICIAN PERFORMED SEVERAL FLUSHES OF SALINE INTO THE RCA, AND FLOW RETURNED WITHIN THE RCA AND THE PATIENT STABILIZED. THERE WAS NO INTERVENTION TO THE PATIENT. THE PATIENT REMAINED STABLE AND WAS MONITORED IN THE USER FACILITY'S INTENSIVE CARE UNIT.

  Patient problems: Air Embolism

  MAUDE report 7294437 ↗