Medical Imaging Solutions Intl. 400109Recalls & reported problems
Medical Imaging Solutions International Company · 2-200ml syringes, 1-60" Y coiled tubing, dual check valves, 2 large spikes YM · 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 00850014500344), received between Jul 12, 2024 and Oct 7, 2024 — classified as 3 malfunctions.
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
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.
MalfunctionOct 7, 2024
WHILE LOADING THE CT ANGIOGRAPHIC SYRINGE, TECH HEARD A "POP" NOTICED THE BOTTOM OF THE SYRINGE RING HAD BROKEN FROM THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20383346 ↗MalfunctionOct 7, 2024
WHILE PURGING THE TUBING FOR THE INJECTOR, THE BOTTOM RING OF THE SYRINGE POPPED OFF WHILE THE INJECTOR WAS MOVING FORWARD. THIS WAS IDENTIFIED BY THE TECH AND THE UNIT WAS STOPPED, RETRACTED THE SYRINGES AND REPLACED WITH NEW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20383152 ↗MalfunctionJul 12, 2024
MISI CT POWER INJECTOR SYRINGE FOUND TO BE BROKEN UPON OPENING OF PACKAGE. THE "MALE CONNECTION NIPPLE" WHERE THE TUBING ATTACHES WAS BROKEN OFF FROM THE TIP OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19728699 ↗
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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