TEMNO® 10884450443191Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
All models of TEMNO (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450443191), received between Dec 10, 2025 and Dec 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking
CUSTOMER ALLEGED WHEN REMOVING THE INNER NEEDLE OF THE INTRODUCER, IT FELT STIFFER THAN USUAL BUT IT COULD BE REMOVED. WHEN ATTEMPTING TO INSERT THE BIOPSY NEEDLE INTO THE COAXIAL INTRODUCER, RESISTANCE WAS ENCOUNTERED APPROXIMATELY 2-3 CM AFTER THE NEEDLE TIP ENTERED INTO THE COAXIAL INTRODUCER. AFTER REPLACING BOTH THE INTRODUCER AND THE BIOPSY NEEDLE WITH NEW ONES, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23772085 ↗
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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 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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