ClariVein® IC 10884450429249Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450429249), received between Aug 28, 2025 and Aug 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2025Fracture; Fracture
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE DEVICE BECAME ENTANGLED, SO THE PHYSICIAN DECIDED TO REPLACE IT. THEY DID NOT NOTICE THAT THE CATHETER TIP DID NOT COME OUT WITH THE REST OF THE EQUIPMENT. SUBSEQUENTLY, THEY DECIDED TO USE ANOTHER DEVICE TO CONTINUE THE PROCEDURE.TEN DAYS LATER, THE PATIENT ATTENDED A FOLLOW-UP APPOINTMENT, REPORTING DISCOMFORT IN THE THIGH. ON ULTRASOUND EVALUATION, THE PHYSICIAN CONFIRMED THE PRESENCE OF CATHETER FRAGMENTS INSIDE THE VEIN, WHICH WERE REMOVED WITHOUT COMPLICATIONS OR CONSEQUENCES FOR THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22911398 ↗
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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 13, 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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