TEMNO EliteRecalls & reported problems across all models
Merit Medical Systems, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 14 models of TEMNO Elite by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2022 and Sep 29, 2026 — classified as 10 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TEMNO Elite problems
Device problems
- Difficult to Remove29
- Activation, Positioning or Separation Problem27
- Positioning Problem27
- Fracture8
- Material Separation4
- Adverse Event Without Identified Device or Use Problem3
- Break3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- Pneumothorax4
- Foreign Body In Patient3
- Air Embolism2
- Hemoptysis1
- Needle Stick/Puncture1
- Pain1
TEMNO Elite models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TEMNO Elite™ 00884450397725INSTRUMENT, BIOPSY19 reports
- TEMNO Elite™ 00884450397763INSTRUMENT, BIOPSY7 reports
- TEMNO Elite™ 00884450397756INSTRUMENT, BIOPSY5 reports
- TEMNO Elite™ 00884450397770INSTRUMENT, BIOPSY5 reports
- TEMNO Elite™ 00884450397619INSTRUMENT, BIOPSY3 reports
- TEMNO Elite™ 00884450397565INSTRUMENT, BIOPSY2 reports
- TEMNO Elite™ 00884450397862INSTRUMENT, BIOPSY2 reports
- TEMNO Elite™ 00884450397602INSTRUMENT, BIOPSY1 report
- TEMNO Elite™ 00884450397640INSTRUMENT, BIOPSY1 report
- TEMNO Elite™ 00884450397657INSTRUMENT, BIOPSY1 report
- TEMNO Elite™ 00884450397664INSTRUMENT, BIOPSY1 report
- TEMNO Elite™ 00884450397718INSTRUMENT, BIOPSY1 report
- TEMNO Elite™ 00884450397879INSTRUMENT, BIOPSY1 report
- TEMNO Elite™ 00884450398104INSTRUMENT, BIOPSY1 report
Recent TEMNO Elite adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionMar 11, 2026Fracture; Material Twisted/Bent
THE ACCOUNT ALLEGES THAT THE BIOPSY NEEDLE BENT IN HALF DURING THE PROCEDURE. UPON PULLING THE DEVICE OUT, IT SNAPPED IN HALF OUTSIDE THE PATIENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24571465 ↗MalfunctionJan 9, 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 24023918 ↗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 ↗MalfunctionDec 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
CUSTOMER ALLEGED WHEN INSERTING THE BIOPSY NEEDLE INTO THE COAXIAL NEEDLE, THERE WAS RESISTANCE AND A GRINDING SOUND DURING INSERTION, SO THE COAXIAL NEEDLE WAS REPLACED WITH A DIFFERENT PRODUCT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854522 ↗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 ↗MalfunctionNov 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 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 23638694 ↗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 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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