High Pressure Tubing 00884450568149Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of High Pressure Tubing (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450568149), 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).
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
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, 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 Tubing, fluid delivery devices
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- High Pressure Tubing CMerit Medical Systems, Inc. · Tubing, fluid delivery1 recall0 reports
- Medex MX43660Icu Medical, Inc. · Tubing, fluid delivery27 reports
- Medex MX43860Icu Medical, Inc. · Tubing, fluid delivery13 reports
- Medex MX452FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- Medex MX451FLIcu Medical, Inc. · Tubing, fluid delivery5 reports
- 10 in. (25 cm) Q2 Checkmate extension set 9545Quest Medical Inc · Tubing, Fluid Delivery3 reports
- Medex MX450FLIcu Medical, Inc. · Tubing, fluid delivery3 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page