TEMNO Elite™ 00884450397770Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450397770), received between Jan 22, 2024 and Jan 6, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 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 23980242 ↗
• 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. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22660709 ↗
• 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 22660670 ↗
• MalfunctionJul 16, 2025Break; Fracture; Break; Fracture

  THE ACCOUNT ALLEGES THAT UPON FIRING THE DEVICE TO COLLECT THE SAMPLE, THE PHYSICIAN NOTICED A PIECE OF THE BIOPSY NEEDLE REMAINED INSIDE THE COAXIAL INTRODUCER. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522767 ↗
• InjuryJan 22, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A BIOPSY PROCEDURE, THE NEEDLE WAS INSERTED WITHIN THE LESION. A PIECE OF THE NEEDLE, APPROXIMATELY 2.0 CENTIMETERS, BROKE OFF WITHIN TH ELESION AFTER TAKING ONE CORE SAMPLE. THE NEEDLE WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE BIOPSY PROCEDURE. THE 2.0 CENTIMETER PIECE OF THE NEEDLE REMAINED WITHIN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18555400 ↗