Blue DiamondRecalls & reported problems across all models
Merit Medical Systems, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Blue Diamond model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 6 models of Blue Diamond by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Jul 2, 2024 and Aug 27, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (6 reports).
2 FDA recall records name at least one of these models by its device 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. 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
Reports received per month, all models
Blue Diamond 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.
- Aug 4, 2025Open, Classified
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Z-0533-2026 · Root cause: Process change control · 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-0064-2025 · Root cause: Packaging process control · names 6 of these models · Recall details · FDA record ↗
Most reported Blue Diamond problems
Device problems
- Tear, Rip or Hole in Device Packaging6
- Manufacturing, Packaging or Shipping Problem1
- Packaging Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Blue Diamond models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Blue Diamond™ 00884450498743Injector and syringe, angiographic2 recalls0 reports
- Blue Diamond™ 00884450381168INJECTOR AND SYRINGE, ANGIOGRAPHIC1 recall6 reports
- Blue Diamond™ 00884450409879Syringe, Balloon Inflation1 recall1 report
- Blue Diamond™ 00884450409855Injector and syringe, angiographic1 recall0 reports
- Blue Diamond™ 00884450409886Injector and syringe, angiographic1 recall0 reports
- Blue Diamond™ 00884450498750Injector and syringe, angiographic1 recall0 reports
Recent Blue Diamond adverse event reports
The 7 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Unsealed Device Packaging; Manufacturing, Packaging or Shipping Problem; Packaging Problem; Unsealed Device Packaging; Manufacturing, Packaging or Shipping Problem; Packaging Problem
THE ACCOUNT ALLEGES THAT THE INNER COMPONENTS OF THE PACKAGING WERE ENTRAPPED WITHIN THE SEAL OF THE OUTER PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909983 ↗MalfunctionJul 2, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT WHEN PREPPING FOR AN INTERVENTIONAL PROCEDURE, THERE WAS A DEFECT IDENTIFIED IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE PACKAGING DEFECT WAS NOT INTUITIVELY OBVIOUS. NO PATIENT CONTACT OR PATIENT INJURY TO REPORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657330 ↗MalfunctionJul 2, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT WHEN PREPPING FOR AN INTERVENTIONAL PROCEDURE, THERE WAS A DEFECT IDENTIFIED IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE PACKAGING DEFECT WAS NOT INTUITIVELY OBVIOUS. NO PATIENT CONTACT OR PATIENT INJURY TO REPORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657329 ↗MalfunctionJul 2, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT WHEN PREPPING FOR AN INTERVENTIONAL PROCEDURE, THERE WAS A DEFECT IDENTIFIED IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE PACKAGING DEFECT WAS NOT INTUITIVELY OBVIOUS. NO PATIENT CONTACT OR PATIENT INJURY TO REPORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657326 ↗MalfunctionJul 2, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT WHEN PREPPING FOR AN INTERVENTIONAL PROCEDURE, THERE WAS A DEFECT IDENTIFIED IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE PACKAGING DEFECT WAS NOT INTUITIVELY OBVIOUS. NO PATIENT CONTACT OR PATIENT INJURY TO REPORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657325 ↗MalfunctionJul 2, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT WHEN PREPPING FOR AN INTERVENTIONAL PROCEDURE, THERE WAS A DEFECT IDENTIFIED IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE PACKAGING DEFECT WAS NOT INTUITIVELY OBVIOUS. NO PATIENT CONTACT OR PATIENT INJURY TO REPORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657324 ↗MalfunctionJul 2, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE ACCOUNT ALLEGES THAT WHEN PREPPING FOR AN INTERVENTIONAL PROCEDURE, THERE WAS A DEFECT IDENTIFIED IN THE PACKAGING RESULTING IN INCOMPLETE STERILIZATION OF THE CONTENTS. THE PACKAGING DEFECT WAS NOT INTUITIVELY OBVIOUS. NO PATIENT CONTACT OR PATIENT INJURY TO REPORT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19657322 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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