Blue Diamond™ 00884450381168Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Blue Diamond (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450381168), received between Jul 2, 2024 and Jul 2, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (6 reports).
1 FDA recall record name this device's identifier, 1 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 18, 2026.
Reports received per month
Recalls naming this device
- 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-0064-2025 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
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 ↗
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- NAMIC 80087007Medline Industries, Inc. · Injector and syringe, angiographic1 recall20 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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