TEMNO Evolution® 10884450443580Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
- 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 10884450443580), received between Dec 4, 2025 and Feb 25, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem2
- Difficult to Remove2
- Positioning Problem2
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.
MalfunctionFeb 25, 2026Difficult to Remove; Activation, Positioning or Separation Problem; Positioning Problem
THE ACCOUNT ALLEGES THAT THE BIOPSY NEEDLE DID NOT FITTING PROPERLY IN THE COAXIAL INTRODUCER. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24447368 ↗MalfunctionDec 4, 2025Difficult to Remove; Activation, Positioning or Separation Problem; Positioning Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Positioning Problem
THE ACCOUNT ALLEGES THAT THE BIOPSY NEEDLE DID NOT FITTING PROPERLY IN THE COAXIAL INTRODUCER. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23718203 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.