ACIST CVi® Contrast Delivery System Power Supply 016226Recalls & reported problems
Acist Medical Systems, Inc. · CVi Power Supply p/n 701340-003 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841716101905), received between Dec 13, 2020 and Dec 13, 2020 — 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathDec 13, 2020Adverse Event Without Identified Device or Use Problem
DURING A LEFT VENTRICLE AND CORONARY CATHETERIZATION (LVC) FOR ELEVATED STRESS, A CORONARY DISSECTION OF THE LEFT MAIN ARTERY OCCURRED AFTER THE SECOND INJECTION OF THE LEFT CORONARY SYSTEM. THE PATIENT'S CONDITION DURING AND AFTER THE EVENT WAS STABLE. THE PATIENT EXPERIENCED CHEST PAIN FOR A PERIOD SUBSEQUENT TO THE EVENT. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, AND IT WAS REPORTED BY THE ACIST CLINICAL SPECIALIST THAT THE PATIENT IS DECEASED.
Patient problems: Vascular Dissection
MAUDE report 10997296 ↗
Other Injector And Syringe, Angiographic devices
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- NAMIC 80085007Medline Industries, Inc. · Injector and syringe, angiographic1 recall36 reports
- NA 622510B. Braun Medical Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC85 reports
- NAMIC 80087007Medline Industries, Inc. · Injector and syringe, angiographic1 recall20 reports
- Blue Diamond™ 00884450381168Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC1 recall6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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