ACIST CVi® Angiographic Injection System Control Panel 017738Recalls & reported problems
Acist Medical Systems, Inc. · CVi Angiographic Injection System Control Panel, p/n 701557-001 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841716101196), received between Jul 24, 2020 and Jul 24, 2020 — classified as 2 deaths.
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 Problem2
Patient problems
- Cardiac Arrest2
- Death2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathJul 24, 2020Adverse Event Without Identified Device or Use Problem
DIAGNOSTIC HEALTH CATH UTILIZING ACIST MEDICAL DEVICE, IMMEDIATELY ON INITIAL INJECTION OF CONTRAST, THE PT EXPERIENCED CARDIOPULMONARY ARREST. UNABLE TO RETURN SPONTANEOUS CIRCULATION AND RESPIRATIONS.
Patient problems: Cardiac Arrest; Death
MAUDE report 10351278 ↗DeathJul 24, 2020Adverse Event Without Identified Device or Use Problem
DIAGNOSTIC HEALTH CATH UTILIZING ACIST MEDICAL DEVICE, IMMEDIATELY ON INITIAL INJECTION OF CONTRAST, THE PT EXPERIENCED CARDIOPULMONARY ARREST. UNABLE TO RETURN SPONTANEOUS CIRCULATION AND RESPIRATIONS.
Patient problems: Cardiac Arrest; Death
MAUDE report 10351266 ↗
Other Injector And Syringe, Angiographic devices
- Monarch® 00884450298022Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls37 reports
- Blue Diamond™ 00884450498743Merit Medical Systems, Inc. · Injector and syringe, angiographic2 recalls0 reports
- Monarch® 00884450298053Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- Monarch® 00884450298060Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page