MonarchRecalls & reported problems across all models

We found 6 models of Monarch by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, 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).

7 FDA recall records name at least one of these models by its device identifier, 7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Monarch recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 30, 2024Class IIOpen, Classified

   Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

   Z-0061-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Aug 30, 2024Class IIOpen, Classified

   Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

   Z-0060-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Aug 30, 2024Class IIOpen, Classified

   Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

   Z-0059-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Aug 30, 2024Class IIOpen, Classified

   Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

   Z-0058-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

5. Aug 30, 2024Class IIOpen, 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 ↗

6. Aug 19, 2024Class IIOpen, 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-0070-2025 · Root cause: Packaging process control · Recall details · FDA record ↗

7. Aug 19, 2024Class IIOpen, 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 · names 3 of these models · Recall details · FDA record ↗

Most reported Monarch problems

Monarch models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Monarch® 00884450298022

  INJECTOR AND SYRINGE, ANGIOGRAPHIC
  2 recalls37 reports
• Monarch® 00884450298053

  INJECTOR AND SYRINGE, ANGIOGRAPHIC
  2 recalls0 reports
• Monarch® 00884450298060

  INJECTOR AND SYRINGE, ANGIOGRAPHIC
  2 recalls0 reports
• Monarch® 00884450236987

  Angiography/angioplasty kit
  1 recall0 reports
• Monarch® 00884450298039

  INJECTOR AND SYRINGE, ANGIOGRAPHIC
  1 recall0 reports
• Monarch® 00884450298046

  INJECTOR AND SYRINGE, ANGIOGRAPHIC
  1 recall0 reports

Recent Monarch adverse event reports

The 15 most recent reports across all models, 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 ↗

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