Merit Medical® 00884450727911Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
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
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450727911), received between Mar 12, 2025 and Mar 12, 2025 — classified as 1 death.
The most frequently reported specific device problem is “Break” (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
- Jun 11, 2024Class IIOpen, Classified
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2569-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Material Separation1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 12, 2025Break; Material Separation; Break; Material Separation
MEDWATCH RECEIVED MW5167050 - THE ACCOUNT ALLEGES THAT IN THE CATH LAB WHILE PERFORMING A PERICARDIAL FLUID DRAINAGE PROCEDURE, THE PATIENT INITIALLY BECAME HEMODYNAMICALLY UNSTABLE AND A CODE BLUE WAS CALLED. THE CODE BLUE WAS TERMINATED PER THE FAMILIES REQUEST AND THE PATIENT EXPIRED. A GUIDEWIRE FROM PERICARDIOCENTESIS KIT WAS FOUND DAMAGED POST PROCEDURE.
Patient problems: Cardiac Arrest
MAUDE report 21584749 ↗
Other Fluid drainage tray devices
- PeriVac™ Kit 00884450486115Merit Medical Systems, Inc. · Fluid drainage tray1 recall8 reports
- Merit Medical® 00884450054017Merit Medical Systems, Inc. · Fluid Drainage Tray1 recall2 reports
- Merit Medical® 00884450727928Merit Medical Systems, Inc. · Fluid drainage tray1 recall0 reports
- PeriVac™ Kit 00884450486061Merit Medical Systems, Inc. · Fluid drainage tray1 recall0 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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