Coeur Acist C465-2042Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M297620420), received between Sep 22, 2021 and Sep 22, 2021 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathSep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COEUR, INC. WAS NOTIFIED BY ACIST MEDICAL SYSTEMS VIA E-MAIL FROM A REGULATORY COMPLIANCE SPECIALIST ON 21 JULY 2021 THAT AN EVENT OCCURRED ON (B)(6) 2021. THE DESCRIPTION OF THE EVENT PROVIDED BY ACIST STATED THAT A PATIENT WAS ADMITTED INTO (B)(6) BY AN EMERGENCY PHYSICIAN ON SUSPICION OF CEREBRAL INFARCTION. FOLLOWING A COMPUTED TOMOGRAPHY (CT) SCAN WITH AN EMPOWERCTA INJECTION SYSTEM, WHICH USED BOTH THE EMPOWERCT FASTLOAD SYRINGE, LOT # 1866032008 AND EMPOWERCTA CONNECTING TUBE, LOT IAQVJ-1903 AS CONSUMABLES), THE PATIENT WENT INTO CARDIAC ARREST 20 MINUTES AFTER THE PROCEDURE. THE USER FACILITY CONSIDERED THAT AIR MAY HAVE BEEN INJECTED INTO THE PATIENT, BUT THIS WAS NOT CONCLUSIVE. IT WAS REPORTED THE PATIENT IS DECEASED.

  Patient problems: Cardiac Arrest

  MAUDE report 12511741 ↗