TEMNO Elite™ 00884450397619Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of TEMNO Elite (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450397619), received between Jul 29, 2025 and Sep 29, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (3 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
- Difficult to Remove3
- Activation, Positioning or Separation Problem2
- Positioning Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927800 ↗MalfunctionJul 29, 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. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22660679 ↗MalfunctionJul 29, 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. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22660671 ↗
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- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 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.
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