MISI-Medical Imaging Solutions International 400109Recalls & reported problems
Canadian Hospital Specialties Limited · CT ANGIOGRAPHIC SYRINGE 2-200ml syringes, 1-60" Y coiled tubing with dual check valves, 2 - Large Spikes, 1 - Fill Staw, 1- Drip Tube with plug · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00628725095141), received between Dec 8, 2025 and Jan 6, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2026
CT SCAN INJECTOR SYRINGE BROKE WHILE INITIALIZING AND MADE A POPPING SOUND. NOT USED ON A PATIENT. STERILE SALINE WAS IN THE SYRINGE. SYRINGE WAS REMOVED AND CHECKED AREA FOR BROKEN PARTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973834 ↗MalfunctionJan 6, 2026
DURING THE INJECTION OF CONTRAST DURING A CTA [COMPUTED TOMOGRAPHY ANGIOGRAPHY] CHEST EXAM, THE RING POPPED OFF THE CONTRAST SIDE OF THE POWER INJECTOR AND SEPARATED FROM THE BASE OF THE SYRINGE. THE SYRINGE WAS UNLOADED, AND A NEW SET OF POWER INJECTABLE SYRINGES WERE LOADED, AND THE EXAM WAS CONTINUED WITHOUT FURTHER INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973718 ↗MalfunctionDec 8, 2025Material Separation
A PATIENT WAS IN PROCESS OF BEING GIVEN IV CONTRAST FOR A CT SCAN, AND DURING INJECTION BY AUTO-INJECTOR ON CT SCANNER, THE SYRINGE SEPARATED FROM BASE; SYRINGE WAS REPLACED AND SCAN WAS PERFORMED WITHOUT FURTHER INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23739122 ↗
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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