TEMNO Elite™ 00884450397763Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450397763), received between Apr 23, 2024 and Apr 30, 2026 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LUNG BIOPSY PROCEDURE, FOLLOWING ACTIVATION OF THE BIOPSY DEVICE, THE OUTER LUMEN DETACHED FROM THE HUB, RESULTING IN THE OUTER LUMEN REMAINING INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE BOTH THE DETACHED COMPONENT AND THE REMAINING DEVICE FROM THE PATIENT WITHOUT COMPLICATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048017 ↗
• MalfunctionApr 22, 2026Fracture

  IT WAS REPORTED THAT DURING A CT LUNG BIOPSY PROCEDURE, THE NEEDLE OF THE BIOPSY DEVICE BROKE OFF INSIDE THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957041 ↗
• 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 22660673 ↗
• MalfunctionJun 10, 2025Difficult to Remove; Activation, Positioning or Separation Problem; Positioning Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Positioning Problem

  THE ACCOUNT ALLEGES THAT DURING USE, THE NEEDLE WOULD NOT PASS THROUGH THE VALVED COAXIAL NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177999 ↗
• MalfunctionJun 10, 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 DURING USE ON A LUNG BIOPSY, THE COAXIAL WITH THE VALVE WAS INSERTED FIRST AND NO RESISTANCE WAS FELT. THE BIOPSY NEEDLE WAS THEN INSERTED AND THE BIOPSY ON THE FLAT TUMOR WAS PERFORMED. UPON ATTEMPTING TO REMOVE THE NEEDLE FROM THE COAXIAL, IT BECAME STUCK AND COULD NOT BE REMOVED. BOTH THE COAXIAL AND NEEDLE WERE REMOVED TOGETHER. MINIMAL BLEEDING WITH NO SERIOUS COMPLICATIONS. PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177916 ↗
• InjuryOct 8, 2024Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance

  THE ACCOUNT ALLEGES THAT THE PHYSICIAN WAS ATTEMPTING A LUNG BIOPSY PROCEDURE, THE INSTRUMENT DID NOT FIRE AND THE BIOPSY NEEDLE DID NOT PASS THROUGH THE COAXIAL NEEDLE SMOOTHLY. DURING THE BIOPSY PROCEDURE THE PATIENT MOVED, RESULTING IN A PNEUMOTHORAX. THE BIOPSY PROCEDURE WAS ABORTED.

  Patient problems: Pneumothorax

  MAUDE report 20404250 ↗
• MalfunctionApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER ALLEGES THAT THE PATIENT DEVELOPED A PNEUMOTHORAX AFTER USE OF ONE OF THE NEEDLES, REQUIRING A CHEST TUBE AND A 2-DAY HOSPITAL STAY. THE PRODUCT WAS DISPOSED OF AFTER USE.

  Patient problems: Pneumothorax

  MAUDE report 19168790 ↗