Safety Paracentesis Procedure TrayRecalls & reported problems across all models
Merit Medical Systems, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Safety Paracentesis Procedure Tray model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 16 models of Safety Paracentesis Procedure Tray by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. 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
Safety Paracentesis Procedure Tray 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.
- Jun 11, 2024Open, 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 · names 16 of these models · Recall details · FDA record ↗
Most reported Safety Paracentesis Procedure Tray 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
Safety Paracentesis Procedure Tray models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Safety Paracentesis Procedure Tray 00884450038710Single use instrument tray1 recall2 reports
- Safety Paracentesis Procedure Tray 00884450038659Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450038673Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450038680Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450038697Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450038703Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450038727Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277522Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277546Paracentesis Tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277560Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277577Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277584Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277591Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277607Paracentesis Tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277645Single use instrument tray1 recall0 reports
- Safety Paracentesis Procedure Tray 00884450277669Paracentesis Tray1 recall0 reports
Recent Safety Paracentesis Procedure Tray adverse event reports
The 2 most recent reports across all models, 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 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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