TEMNO Elite™ 00884450397725Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00884450397725), received between Mar 26, 2024 and Jul 27, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (12 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Detachment of Device or Device Component

  During malignant lymphoma biopsy of a hard retroperitoneal tissue after one successfull firing, during second firing, the patient complained of pain. When the needle was withdrawn from the body, the needle tip was missing and had remained inside the patient. The fractured needle tip was subsequently retrieved via open surgery.

  Patient problems: Pain

  MAUDE report 50010285 ↗
• MalfunctionMar 30, 2026Complete Blockage

  IT WAS REPORTED THAT THE BIOSENTRY PLUNGER STYLETTE WILL NOT PASS THROUGH COAXIAL ADAPTER TO PUSH OUT BIO-SEAL PLUG. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730630 ↗
• MalfunctionDec 19, 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 23854024 ↗
• MalfunctionDec 5, 2025Difficult to Advance; Difficult to Advance

  THE ACCOUNT ALLEGES THAT DURING USE THE DEVICE COULD NOT ADVANCE THROUGH TO COAXIAL INTRODUCER. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728444 ↗
• MalfunctionOct 28, 2025Break; Break

  A TUMOR BIOPSY WAS PERFORMED ON A PATIENT SUSPECTED OF HAVING LIVER METASTASES. SKIN WAS FIRM, AND RESISTANCE WAS ENCOUNTERED WHEN PUNCTURING THE DERMIS, BUT COMPARED TO OTHER CASES, THE TUMOR AND LIVER DID NOT FEEL HARD. WHEN ATTEMPTING TO PUSH OUT THE INNER BARREL, IT DID NOT COME OUT, BUT THE FIRING WAS PERFORMED ANYWAY. UPON WITHDRAWING THE BIOPSY NEEDLE, THE TIP OF THE INNER BARREL) WAS FRACTURED APPROXIMATELY 1.5 CM (NOTCH PART OF THE PRODUCT. THE TIP REMAINED BETWEEN THE LIVER AND PERITONEUM/ SURFACE OF LIVER, AND THE PORTION OF THE PRODUCT LEFT IN THE PATIENT'S BODY WAS SUCCESSFULLY RETRIEVED AS OF (B)(6) VIA SURGICAL OPERATION. THE PATIENT'S CONDITION REMAINS STABLE AS OF MORNING ON (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 23405573 ↗
• MalfunctionSep 18, 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 23085422 ↗
• MalfunctionAug 28, 2025Difficult to Insert; Difficult to Insert

  THE ACCOUNT ALLEGES THAT THE BIOPSY NEEDLE COULD NOT BE INSERTED INTO THE INTRODUCER. ANOTHER ONE FROM THE SAME LOT WAS USED INSTEAD, WHICH WORKED WITHOUT ANY PROBLEMS. THE INTRODUCER WAS NOT REPLACED OR REINSERTED, ONLY THE NEWLY OPENED BIOPSY NEEDLE BODY WAS REINSERTED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911609 ↗
• MalfunctionAug 27, 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 22909967 ↗
• MalfunctionJun 24, 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 PREP FOR PROCEDURE THEY ATTEMPTED TO PUT BIOPSY NEEDLE THROUGH THE VALVED COAXIAL INTRODUCER NEEDLE AND IT WOULD NOT PASS THROUGH. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321219 ↗
• MalfunctionJun 24, 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 PREP FOR PROCEDURE THEY ATTEMPTED TO PUT BIOPSY NEEDLE THROUGH THE VALVED COAXIAL INTRODUCER NEEDLE AND IT WOULD NOT PASS THROUGH. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321218 ↗
• MalfunctionJun 24, 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 PREP FOR PROCEDURE THEY ATTEMPTED TO PUT BIOPSY NEEDLE THROUGH THE VALVED COAXIAL INTRODUCER NEEDLE AND IT WOULD NOT PASS THROUGH. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321217 ↗
• MalfunctionJun 24, 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 PHYSICIAN NOTICED DURING A LUNG BIOPSY. THE BIOPSY NEEDLE WOULD NOT PASS THROUGH THE COAXIAL NEEDLE TO OBTAIN A SAMPLE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321210 ↗
• MalfunctionJun 24, 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 THE PROCEDURE, AFTER THE OUTER TUBE NEEDLE WAS INSERTED INTO THE PATIENT'S BODY, IT WAS FOUND THAT THE BIOPSY NEEDLE COULD NOT BE INSERTED INTO THE OUTER TUBE NEEDLE. ANOTHER ONE FROM THE DIFFERENT LOT WAS OPENED AND USED INSTEAD. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321209 ↗
• MalfunctionJun 24, 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 PREP FOR PROCEDURE THEY ATTEMPTED TO PUT BIOPSY NEEDLE THROUGH THE VALVED COAXIAL INTRODUCER NEEDLE AND IT WOULD NOT PASS THROUGH. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321204 ↗
• MalfunctionJun 18, 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, AN ATTEMPT WAS MADE TO INSERT THE BIOPSY NEEDLE INTO THE VALVED COAXIAL, THE RUBBER PART OF THE VALVE PASSED THROUGH, BUT AFTER THAT POINT THE BIOPSY NEEDLE BECAME STUCK AND COULD NOT BE INSERTED INTO THE INTERIOR AND IT WAS UNUSABLE. ANOTHER BIOPSY DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286355 ↗
• 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 A LUNG BIOPSY, THE NEEDLE WOULD NOT PASS THROUGH THE VALVED COAXIAL NEEDLE. ANOTHER DEVICE WAS USED AND PASSED EASILY THROUGH TO COAXIAL. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177936 ↗
• 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, AN ATTEMPT WAS MADE TO INSERT THE BIOPSY NEEDLE INTO THE VALVED COAXIAL, THE RUBBER PART OF THE VALVE PASSED THROUGH, BUT AFTER THAT POINT THE BIOPSY NEEDLE BECAME STUCK AND COULD NOT BE INSERTED INTO THE INTERIOR AND IT WAS UNUSABLE. ANOTHER BIOPSY DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177918 ↗
• MalfunctionJun 10, 2025Compatibility Problem; Compatibility Problem

  THE ACCOUNT ALLEGES THAT THE COAXIAL WAS PLACED IN THE PATIENT, ATTEMPTED TO PASS THE TEMNO ELITE NEEDLE THROUGH COAXIAL AND IT WOULD NOT FIT. A SECOND TEMNO ELITE OPENED PASSED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176203 ↗
• InjuryMar 26, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNTED ALLEGES THAT DURING A DIAGNOSTIC PROCEDURE, THE DEVICE WAS USED TO SUCCESSFULLY OBTAIN A BIOPSY SAMPLE. HOWEVER, WHILE ATTEMPTING TO ADVANCE THE SAMPLE INTO A SPECIMEN JAR THE HANDLE OF THE DEVICE BROKE APART AND THE CLINICIAN SUFFERED A NEEDLE STICK INJURY. THE CLINICIAN UNDERWENT MANDATORY BBP TESTING AND THE INJURY WAS CLEANED PER HOSPITAL PROTOCOL. A SECOND DEVICE WAS USED TO SUCCESSFULLY OBTAIN AND DEPOSIT A PATIENT BIOPSY SAMPLE INTO THE SPECIMEN JAR WITHOUT INCIDENT. NO ADDITIONAL PATIENT OR CLINICIAN CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983986 ↗