ACIST CVi® Angiographic Injection System Injector Head 014658Recalls & reported problems
Acist Medical Systems, Inc. · CVi Injector (Siemens), p/n 700708-009 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841716101349), received between Oct 19, 2017 and Oct 19, 2017 — classified as 2 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
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Vascular Dissection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT DURING A CASE USING THE ACIST ANGIOGRAPHIC CONTRAST DELIVERY SYSTEM, MODEL CVI SIEMENS, A DISSECTION OF THE RIGHT CORONARY ARTERY (RCA) OCCURRED. THE EXACT DATE THE CASE OCCURRED WAS NOT REPORTED AND IS UNKNOWN. THE PATIENT WAS UNDERGOING A PROCEDURE FOR LEFT HEART CATHETERIZATION (LHC) WITH POSSIBLE PERCUTANEOUS CORONARY INTERVENTION (PCI) WHEN THE DISSECTION OCCURRED. THE DISSECTION WAS SUCCESSFULLY REPAIRED WITH A STENT AND THE PATIENT RECOVERED.
Patient problems: Vascular Dissection
MAUDE report 6963508 ↗InjuryOct 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT DURING A CASE USING THE ACIST ANGIOGRAPHIC CONTRAST DELIVERY SYSTEM, MODEL CVI SIEMENS, A DISSECTION OF THE LEFT INTERNAL MAMMARY ARTERY (LIMA) OCCURRED. THE EXACT DATE THE CASE OCCURRED WAS NOT REPORTED AND IS UNKNOWN. THE PATIENT WAS UNDERGOING A PROCEDURE FOR LEFT HEART CATHETERIZATION (LHC) WITH POSSIBLE PERCUTANEOUS CORONARY INTERVENTION (PCI) WHEN THE DISSECTION OCCURRED. THE DISSECTION WAS SUCCESSFULLY REPAIRED WITH A STENT AND THE PATIENT SUBSEQUENTLY RECOVERED.
Patient problems: Vascular Dissection
MAUDE report 6963498 ↗
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.
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