Safety Paracentesis Procedure Tray 00884450038710Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
All models of Safety Paracentesis Procedure Tray (16)
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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450038710), received between Mar 9, 2026 and Mar 12, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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-2576-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
- Obstruction of Flow1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Obstruction of Flow; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT DURING A THERAPEUTIC PARACENTESIS PROCEDURE, THE PHYSICIAN REPORTED THAT THE CATHETER WAS NOT DRAINING. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE CATHETER TIP WAS MISSING. ULTRASOUND IMAGING CONFIRMED THAT THE CATHETER TIP WAS RETAINED IN THE SUBCUTANEOUS TISSUE OF THE RIGHT LOWER QUADRANT OF THE ABDOMEN. SURGICAL CONSULTATION WAS OBTAINED AND REMOVAL OF THE RETAINED FRAGMENT WAS SCHEDULED. THE DEVICE AND PACKAGING WERE NOT RETAINED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583327 ↗InjuryMar 9, 2026Fracture
ACCOUNT REPORTED THE ONE-STEP 5 FRENCH 7C 8MM CATHETER WAS BEING USED DURING A RADIOLOGICAL PROCEDURE. THE PROVIDER NOTED THAT THE CATHETER WAS NOT DRAINING DURING A ROUTINE THERAPEUTIC PARACENTESIS. THE DOCTOR REMOVED THE CATHETER AND DISCOVERED THAT THE TIP OF THE CATHETER WAS NO LONGER PRESENT. ULTRASOUND SHOWED THAT THE TIP WAS RETAINED AND PRESENT IN THE SUBCUTANEOUS TISSUE OF THE RIGHT LOWER QUADRANT OF THE ABDOMEN. SURGERY WAS CONSULTED AND SCHEDULED. UNFORTUNATELY, NEITHER THE PACKAGING OR THE CATHETER ITSELF WAS SAVED BY THE DIAGNOSTIC RADIOLOGY STAFF.
Patient problems: Foreign Body In Patient
MAUDE report 24550807 ↗
Other Single use instrument tray devices
- Safety Paracentesis Procedure Tray 00884450038697Merit Medical Systems, Inc. · Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450038659Merit Medical Systems, Inc. · Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450038703Merit Medical Systems, Inc. · Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277577Merit Medical Systems, Inc. · Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277560Merit Medical Systems, Inc. · Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277591Merit Medical Systems, Inc. · Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450038680Merit Medical Systems, Inc. · Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450038727Merit Medical Systems, Inc. · Single use instrument 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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