High Pressure TubingRecalls & reported problems across all models
Merit Medical Systems, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one High Pressure Tubing 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 3 models of High Pressure Tubing 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 Aug 6, 2025 and Aug 6, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
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
High Pressure Tubing 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 5, 2025Class IIOpen, Classified
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Z-2293-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported High Pressure Tubing problems
Device problems
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
High Pressure Tubing models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- High Pressure Tubing CTubing, fluid delivery1 recall0 reports
- High Pressure Tubing CTubing, fluid delivery1 recall0 reports
- High Pressure Tubing 00884450568149Tubing, fluid delivery2 reports
Recent High Pressure Tubing adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Material Fragmentation; Material Fragmentation
THE ACCOUNT ALLEGES THAT THE THREAD ON THE TUBING WAS BROKEN AND CAME OFF INSIDE THE COBRA PROBE. THE DEVICE WAS REPLACED AND PROCEDURE WAS CONTINUED WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22731604 ↗MalfunctionAug 6, 2025Material Fragmentation; Material Fragmentation
THE ACCOUNT ALLEGES THAT THE THREAD ON THE TUBING WAS BROKEN AND CAME OFF INSIDE THE COBRA PROBE. THE DEVICE WAS REPLACED AND PROCEDURE WAS CONTINUED WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22731601 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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