Monarch® 00884450298022Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Monarch (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Merit Medical Monarch angiographic injector and syringe is used to deliver contrast fluid during procedures. Most of the 37 reports describe packaging that arrived unsealed, torn or punctured, which the accounts say could mean the sterile barrier was broken and the contents not fully sterilized. Two reports describe injuries; no deaths. Two open recalls, both starting in August 2024, say holes in the Tyvek sterile barrier from the manufacturing and packaging process could expose the device to contamination.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00884450298022), received between Dec 3, 2019 and Jul 20, 2021 — classified as 2 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Unsealed Device Packaging” (16 reports).
2 FDA recall records name this device's identifier, 2 still open.
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 16, 2026.
Recalls naming this device
- Aug 30, 2024Open, Classified
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Z-0057-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Aug 19, 2024Open, Classified
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Z-0069-2025 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Unsealed Device Packaging16
- Tear, Rip or Hole in Device Packaging13
- Material Puncture/Hole3
- Packaging Problem3
- Defective Component1
- Fluid/Blood Leak1
- Fracture1
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- Air Embolism1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12199278 ↗MalfunctionJul 20, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12199259 ↗MalfunctionJul 20, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12199254 ↗MalfunctionJul 20, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12199207 ↗InjuryJul 20, 2021Defective Component; Defective Component
THE ACCOUNT ALLEGES THAT DURING AN ANGIOPLASTY PROCEDURE, THE CUSTOM KIT PRESENTED A DEFECT THAT CAUSED AIR INGRESS INTO THE FLUID PATHWAY. AIR BUBBLES WERE THEN INJECTED INTO THE RIGHT CORONARY ARTERY CAUSING ST SEGMENT ELEVATION AS SEEN ON THE ECG.
Patient problems: Air Embolism
MAUDE report 12199196 ↗MalfunctionJul 20, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12199193 ↗MalfunctionJun 30, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12092762 ↗MalfunctionJun 30, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12092757 ↗MalfunctionJun 30, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12092756 ↗MalfunctionJun 29, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12088472 ↗MalfunctionJun 16, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12009832 ↗MalfunctionJun 8, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A BREACH IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11962163 ↗MalfunctionJun 8, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A HOLE IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11962109 ↗MalfunctionMay 25, 2021Gas/Air Leak; Gas/Air Leak
THE ACCOUNT ALLEGES THAT DURING A PCI PROCEDURE, THE MANIFOLD KIT PULLED AIR IN THROUGH THE TUBING AND SYRINGE. NO ADVERSE EVENT OR INJURY OCCURRED AS NO AIR WAS INJECTED INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11882105 ↗MalfunctionMay 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A HOLE IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11849565 ↗MalfunctionMay 6, 2021Problem with Sterilization; Problem with Sterilization
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING SEAL RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THIS WAS IDENTIFIED DURING AN INITIAL INSPECTION OF RECEIVED PRODUCT. THE DEVICE WAS NOT SENT TO A USER FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11784284 ↗MalfunctionFeb 23, 2021Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11364873 ↗MalfunctionFeb 23, 2021Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11364872 ↗MalfunctionFeb 2, 2021Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11269858 ↗MalfunctionFeb 2, 2021Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11269831 ↗MalfunctionDec 15, 2020Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION, OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013195 ↗MalfunctionDec 15, 2020Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013091 ↗MalfunctionDec 15, 2020Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013080 ↗MalfunctionDec 9, 2020Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THIS DEFECT WAS FOUND DURING THE DISTRIBUTOR'S INITIAL INSPECTION OF RECEIVED PRODUCTS. THE DEVICE WAS NOT SENT TO A USER FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10979923 ↗MalfunctionDec 8, 2020Unsealed Device Packaging; Unsealed Device Packaging
THE ACCOUNT ALLEGES THAT THERE WAS A DEFECT IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE DEFECT WAS IDENTIFIED DURING PREPARATIONS FOR A MEDICAL PROCEDURE. NO PATIENT INTERACTION OR INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10971889 ↗
Other INJECTOR AND SYRINGE, ANGIOGRAPHIC devices
- Monarch® 00884450298060Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- Blue Diamond™ 00884450498743Merit Medical Systems, Inc. · Injector and syringe, angiographic2 recalls0 reports
- Monarch® 00884450298053Merit 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
- FastLoad™ CT Syringe Pack 017344Bracco Injeneering SA · Injector And Syringe, Angiographic1 recall4 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 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