Blue Diamond™ 00884450409879Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450409879), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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
- Manufacturing, Packaging or Shipping Problem1
- Packaging Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
Other Syringe, Balloon Inflation devices
- Indeflator 1000184Abbott Vascular Inc. · Syringe, balloon inflation2 recalls155 reports
- Indeflator 1000186-115Abbott Vascular Inc. · Syringe, balloon inflation2 recalls124 reports
- Alliance II M00550600Boston Scientific Corporation · Syringe, balloon inflation191 reports
- Indeflator 1000185Abbott Vascular Inc. · Syringe, balloon inflation1 recall131 reports
- Indeflator 1000186Abbott Vascular Inc. · Syringe, balloon inflation2 recalls56 reports
- Encore™ 26 M001151050Boston Scientific Corporation · Syringe, balloon inflation1 recall54 reports
- PRESTO ID4030Bard Peripheral Vascular, Inc. · Syringe, balloon inflation1 death98 reports
- Encore™ 26 Advantage Kit H74904527011Boston Scientific Corporation · Syringe, balloon inflation1 recall28 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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