Tru-Core II Biopsy InstrumentRecalls & reported problems across all models
Argon Medical Devices, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Tru-Core II Biopsy Instrument model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 8 models of Tru-Core II Biopsy Instrument by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2020 and Apr 23, 2025 — classified as 2 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Failure to Obtain Sample” (3 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Tru-Core II Biopsy Instrument recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 2, 2024Class IIOpen, Classified
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
Z-3192-2024 · Root cause: Packaging change control · names 8 of these models · Recall details · FDA record ↗
Most reported Tru-Core II Biopsy Instrument problems
Device problems
- Failure to Obtain Sample3
- Break2
- Material Deformation2
- Physical Resistance/Sticking2
- Therapeutic or Diagnostic Output Failure2
- Defective Component1
- Defective Device1
- Device Markings/Labelling Problem1
Patient problems
- Hematoma3
- No Clinical Signs, Symptoms or Conditions3
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information2
- Needle Stick/Puncture2
- No Known Impact Or Consequence To Patient2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Tru-Core II Biopsy Instrument models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tru-Core™ II Biopsy Instrument 763116100XInstrument, Biopsy1 recall4 reports
- Tru-Core™ II Biopsy Instrument 763116160XInstrument, Biopsy1 recall3 reports
- Tru-Core™ II Biopsy Instrument 763114100XInstrument, Biopsy1 recall3 reports
- Tru-Core™ II Biopsy Instrument 763120160XInstrument, Biopsy1 recall2 reports
- Tru-Core™ II Biopsy Instrument 763118100XInstrument, Biopsy1 recall1 report
- Tru-Core™ II Biopsy Instrument 763120100XInstrument, Biopsy1 recall0 reports
- Tru-Core™ II Biopsy Instrument 763114200XInstrument, Biopsy1 recall0 reports
- Tru-Core™ II Biopsy Instrument 763118200XInstrument, Biopsy1 recall0 reports
Recent Tru-Core II Biopsy Instrument adverse event reports
The 13 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Material Fragmentation; Material Fragmentation
A DIRECTOR OF IMAGING REPORTED "WE USED THIS BIOPSY DEVICE AND ON THE POST PROCEDURE MAMMOGRAM, THE RADIOLOGIST NOTICED LINEAR/METALLIC ARTIFACT NEAR THE CLIP THAT WAS DEPLOYED. THEY BELIEVE THIS CAME FROM THE BIOPSY DEVICE. MAMMOTME HYDROMARK PLACED AFTER BIOPSY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21892461 ↗MalfunctionJul 2, 2024Firing Problem; Firing Problem
IN AN ELECTIVE KIDNEY BIOPSY WITH A BIOPSY INSTRUMENT, THE FOLLOWING INCIDENT CAN BE REPORTED TODAY, THE TENSIONED BIOPSY NEEDLE WAS INSERTED INTO THE PATIENT. AFTER ACTIVATING THE TRIGGER MECHANISM, THE DEVICE FIRED A "SHOT" AS INTENDED. WHEN PULLING IT OUT, HOWEVER, THE SHIELD ABOVE THE NEEDLE WAS OPEN AND THE DEVICE COULD NOT BE TENSIONED AGAIN. THE BIOPSY CYLINDER WAS LOST, SO THE PATIENT WAS UNNECESSARILY SUBJECTED TO A INCREASED RISK BECAUSE IT HAD TO BE BIOPSIED AGAIN.
Patient problems: Insufficient Information
MAUDE report 19662648 ↗MalfunctionMar 28, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
THE DEVICE WAS USED FOR BREAST BIOPSY. AT THE 3RD BIOPSY WITH THE DEVICE, THE DEVICE WAS NOT ABLE TO REMOVE FROM THE PATIENT AFTER FIRING DUE TO STORONG RESISTANCE. THE PHYSICIAN ATTEMPTED TO REMOVE THE STUCK NEEDLE BY ROTATING AND PUSHING FORWARD/BACKWARD THE DEVICE AND THEN FINALLY ABLE TO BE PULLED OUT. THERE WAS A RISK TO CAUSE EXTRA BLEEDING. THE DEVICE WAS SWITCHED TO ANOTHER NEW ONE TO COMPLETE THE BIOPSY. SUGAN COMMENT UPON CHECK OF THE RETURNED PRODUCT; THE DEVICE WAS ABLE TO SET IN READY POSITION, HOWEVER, AN ABNORMALITY WAS CONFIRMED AT THE SETTING MOTION. WHEN KNOB 1 WAS BEING PULLED DOWN, KNOB 2 ALSO MOVED ALONG WITH KNOB 1.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16630993 ↗MalfunctionFeb 6, 2023Failure to Obtain Sample; Failure to Obtain Sample
TRUCORE 14G AND 16G USED FOR MAMMAE BIOPSY. NO CO-AXIAL NEEDLE USED. COMPLAINT THAT THEY DON`T GET A FULL 19MM SAMPLE. THEREFORE, THEY HAD TO REPEAT THE PROCEDURE SEVERAL TIMES AND IT RESULTED IN A HEMATOMA. THEY HAVE THE IMPRESSION THAT THE NEEDLE ISN`T SHARP BECAUSE IT FASTENED TO THE PARENCHYMA AND THEY HAD TO USE EXTRA FORCE TO GET IT OUT.
Patient problems: Hematoma
MAUDE report 16307303 ↗MalfunctionFeb 6, 2023Failure to Obtain Sample; Failure to Obtain Sample
TRUCORE 14G AND 16G USED FOR MAMMAE BIOPSY. NO CO-AXIAL NEEDLE USED. COMPLAINT THAT THEY DON`T GET A FULL 19MM SAMPLE. THEREFORE, THEY HAD TO REPEAT THE PROCEDURE SEVERAL TIMES AND IT RESULTED IN A HEMATOMA. THEY HAVE THE IMPRESSION THAT THE NEEDLE ISN`T SHARP BECAUSE IT FASTENED TO THE PARENCHYMA AND THEY HAD TO USE EXTRA FORCE TO GET IT OUT.
Patient problems: Hematoma; Needle Stick/Puncture
MAUDE report 16307167 ↗MalfunctionFeb 6, 2023Failure to Obtain Sample; Failure to Obtain Sample
TRUCORE 14G AND 16G USED FOR MAMMAE BIOPSY. NO CO-AXIAL NEEDLE USED. COMPLAINT THAT THEY DON`T GET A FULL 19MM SAMPLE. THEREFORE, THEY HAD TO REPEAT THE PROCEDURE SEVERAL TIMES AND IT RESULTED IN A HEMATOMA. THEY HAVE THE IMPRESSION THAT THE NEEDLE ISN`T SHARP BECAUSE IT FASTENED TO THE PARENCHYMA AND THEY HAD TO USE EXTRA FORCE TO GET IT OUT.
Patient problems: Hematoma; Needle Stick/Puncture
MAUDE report 16304942 ↗MalfunctionOct 23, 2022Break; Entrapment of Device; Material Deformation
MOVED TO A POSTERIOR APPROACH FOR THE NEXT ATTEMPT. AFTER IMAGING THEY NOTICED A SMALL METALLIC OBJECT FOR THE FIRST TIME AND WHEN HE LOOKED AT THE BIOPSY DEVICE HE NOTICED THE TIP MISSING AND SLIGHT DEFORMED LOOK. THE DEVICE ONLY HAD ONE PASS WHEN TIP BROKE OFF. THEY USED ANOTHER TRU CORE DEVICE SUCCESSFULLY. THE NODULE WAS NEAR RIB CAGE BONE AND IT IS A POSSIBILITY CONTACT TO BONE WAS MADE, BUT THE OPERATOR DID NOT FEEL ANY TACTILE FEEDBACK THAT SUGGESTED THIS. THE PATIENT SAW FURTHER EVALUATION TO SEE IF SURGICAL REMOVAL WAS NEEDED AND THE SURGEON ADVISED AGAINST IT. THE TIP IS IN THE PLURAL SPACE OF THE PATIENT. NOTE- UPON RECEIVING THE DEVICE, THE TIP IS BENT AT NEARLY A 90 DEGREE ANGLE. THE OPERATING DOCTOR SAID THIS TYPE OF BEND DID NOT OCCUR DURING THE PROCEDURE AND MUST HAVE HAPPENED AFTER HANDLING FOR THE PER. THE AREA OF FOCUS IS THE DISTAL TIP. ARGON 19G COAXIAL INTRODUCER MCXS2016TY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15656408 ↗MalfunctionJul 21, 2022Material Deformation; Therapeutic or Diagnostic Output Failure
THE TIP OF THE NEEDLE IS DAMAGED AND THE TISSUE CANNOT BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15075838 ↗InjuryJul 21, 2021Break; Therapeutic or Diagnostic Output Failure
RENAL PUNCTURE WAS PERFORMED IN THREE PATIENTS, AND BLEEDING OCCURRED IN TWO PATIENTS; ANOTHER PATIENT WAS UNABLE TO TAKE OUT THE TISSUE AT THE FIRST PUNCTURE, AND THE NEEDLE IS DAMAGED. FOUR BP WERE REPLACED CONTINUOUSLY. AT THE FIFTH PUNCTURE, A LARGE AMOUNT OF BLEEDING AND NECROSIS OF THE RIGHT KIDNEY OCCURRED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Necrosis
MAUDE report 12205158 ↗MalfunctionDec 28, 2020Retraction Problem; Physical Resistance/Sticking
InjuryNov 23, 2020Device Markings/Labelling Problem
MalfunctionJun 18, 2020Defective Device
IT CANNOT LOCK DURING PROCEDURE AND ONE MORE PIC CANNOT TAKE THE SAMPLE AFTER SHOOTING INTO THE PATIENT TISSUE
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10171683 ↗MalfunctionJun 18, 2020Defective Component
IT CANNOT LOCK DURING PROCEDURE AND ONE MORE PIC CANNOT TAKE THE SAMPLE AFTER SHOOTING INTO THE PATIENT TISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10171541 ↗
Other Argon Medical Devices, Inc. products
- First PICC S/L Peripherally Inserted Central Catheter5 models · 174 reports
- BioPince Ultra Full Core Biopsy Instrument10 models · 85 reports · 1 recall
- BioPince Full Core Biopsy Instrument5 models · 60 reports · 1 recall
- L-Cath PICC S/L2 models · 30 reports · 1 recall
- Scorpion2 models · 7 reports · 1 recall
- Arterial Line Kit2 models · 2 reports · 1 recall
- Tru-Core II URO Biopsy Instrument2 models · 2 reports · 1 recall
- Transvenous Pacing Electrode Tray2 models · 0 reports · 1 recall
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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