TEMNO Elite™ 00884450397756Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450397756), received between Oct 11, 2022 and Mar 24, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. 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.

• InjuryMar 24, 2026Difficult to Remove

  THE ACCOUNT ALLEGES THAT DURING BIOPSY PROCEDURE, THE PROVIDER WAS MET WITH RESISTANCE WEN REMOVING THE NEEDLE. THE NEEDLE CAME OUT BENT. THE PATIENT EXPERIENCED HEMOPTYSIS AND A SMALL PNEUMOTHORAX.

  Patient problems: Hemoptysis; Pneumothorax

  MAUDE report 24675883 ↗
• 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 22660687 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A LUNG BIOPSY, AN OUTPATIENT EXPERIENCED AN AIR EMBOLISM. THE PATIENT WAS INTUBATED AND TRANSFERRED TO ICU FOR FURTHER OBSERVATION.

  Patient problems: Air Embolism

  MAUDE report 19944549 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A LUNG BIOPSY, AN OUTPATIENT EXPERIENCED AN AIR EMBOLISM. THE PATIENT WAS INTUBATED AND TRANSFERRED TO ICU FOR FURTHER OBSERVATION.

  Patient problems: Air Embolism

  MAUDE report 19943156 ↗
• InjuryOct 11, 2022Material Twisted/Bent; Material Twisted/Bent

  THE ACCOUNT ALLEGES THAT DURING USE OF A BIOPSY NEEDLE, IT BENT AND THE PATIENT SUFFERED PNEUMOTHORAX. THE PHYSICIAN IS UNSURE AS TO WHETHER OR NOT THE BIOPSY DEVICE CONTRIBUTED TO THE DEVELOPMENT OF THE PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 15583956 ↗