Thoracentesis and Paracentesis SetRecalls & reported problems across all models
Merit Medical Systems, Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Thoracentesis and Paracentesis Set 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
- 0
- Recalls
- 1
We found 19 models of Thoracentesis and Paracentesis Set 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 May 23, 2023 and May 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
Thoracentesis and Paracentesis Set 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 19 of these models · Recall details · FDA record ↗
Most reported Thoracentesis and Paracentesis Set problems
Device problems
- Fluid/Blood Leak1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Thoracentesis and Paracentesis Set models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Thoracentesis and Paracentesis Set 00884450038741CATHETER, IRRIGATION1 recall1 report
- Thoracentesis and Paracentesis Set 00884450038758CATHETER, IRRIGATION1 recall1 report
- Thoracentesis and Paracentesis Set 00884450038734Single use instrument tray1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450038765CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450038772CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277737CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277751Thoracentesis Tray1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277775CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277782CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277799CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277805CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277812Thoracentesis Tray1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277843Thoracentesis Tray1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277850CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277867CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277874CATHETER, IRRIGATION1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277881Thoracentesis Tray1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277898Thoracentesis Tray1 recall0 reports
- Thoracentesis and Paracentesis Set 00884450277904CATHETER, IRRIGATION1 recall0 reports
Recent Thoracentesis and Paracentesis Set adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Fracture; Fracture
THE ACCOUNT ALLEGES THE VALVE ON THE ONE STEP SEPARATED FROM THE HUB. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061196 ↗MalfunctionMay 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT FLUID WAS FOUND LEAKING FROM THE CATHETER AND A SMALL CRACK NEAR THE HUB. THE CATHETER WAS REMOVED INTACT, AND WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16986009 ↗
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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