SuperCore Biopsy InstrumentRecalls & reported problems across all models
Argon Medical Devices, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 9 models of SuperCore Biopsy Instrument by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Jul 16, 2020 and Jan 28, 2026 — classified as 7 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Break” (14 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 SuperCore Biopsy Instrument problems
Device problems
- Break14
- Firing Problem7
- Nonstandard Device6
- Detachment of Device or Device Component5
- Material Twisted/Bent2
- Physical Resistance/Sticking2
- Adverse Event Without Identified Device or Use Problem1
- Component Misassembled1
Patient problems
- Insufficient Information12
- No Clinical Signs, Symptoms or Conditions10
- Needle Stick/Puncture8
- Hemorrhage/Blood Loss/Bleeding2
- No Known Impact Or Consequence To Patient1
- Pain1
- Swelling/ Edema1
SuperCore Biopsy Instrument models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SuperCore™ Biopsy Instrument 701118150Instrument, Biopsy12 reports
- SuperCore™ Biopsy Instrument 701118090Instrument, Biopsy5 reports
- SuperCore™ Biopsy Instrument 701118060Instrument, Biopsy5 reports
- SuperCore™ Biopsy Instrument 701116090Instrument, Biopsy3 reports
- SuperCore™ Biopsy Instrument 701218150Instrument, Biopsy3 reports
- SuperCore™ Biopsy Instrument 701116150Instrument, Biopsy2 reports
- SuperCore™ Biopsy Instrument 701218200Instrument, Biopsy2 reports
- SuperCore™ Biopsy Instrument 701120090Instrument, Biopsy1 report
- SuperCore™ Biopsy Instrument 701218090Instrument, Biopsy1 report
Recent SuperCore Biopsy Instrument adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2026Component Misassembled
THE REPORTER STATED "THE BIOPSY NEEDLE DID NOT MATCH THE COAXIAL NEEDLE. ANOTHER BIOPSY NEEDLE WAS USED INSTEAD TO COMPLETE THE OPERATION, CAUSING A SLIGHT INJURY TO THE PATIENT."
Patient problems: Insufficient Information
MAUDE report 24206094 ↗MalfunctionNov 23, 2025Break; Break
A PHYSICIAN REPORTED THAT HE COLLECTED THE FRAGMENT, WHEN REMOVING THE SAMPLE FROM THE TRIGGER INSIDE THE NEEDLE, IT BROKE AND CAME LOOSE FROM THE NEEDLE. THE NEEDLE WAS CONTAMINATED AND DUE TO THE RISK OF CONTAMINATION, IT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23626986 ↗InjuryMay 1, 2025Material Twisted/Bent; Material Twisted/Bent
WHEN USING A BIOPSY NEEDLE TO PERFORM BREAST PUNCTURE ON A PATIENT'S BREAST MASS, IT IS DIFFICULT TO PUNCTURE THE NEEDLE. IT WAS FOUND THAT THE NEEDLE HAS A BENT GROOVE, WHICH POSES A RISK OF DAMAGING THE SURROUNDING TISSUE OF THE MASS. IT IS NECESSARY TO REMOVE THE BIOPSY NEEDLE AGAIN, STRAIGHTEN THE VALVE, AND RE PUNCTURE, WHICH MAY CAUSE THE MASS TISSUE TO OVERFLOW DURING PUNCTURE.
Patient problems: Insufficient Information
MAUDE report 21945313 ↗InjuryApr 23, 2025Firing Problem; Firing Problem
THE REPORTER STATED, "THE TRIGGER MECHANISM IS NOW EXTREMELY STIFF, AND IN SOME CASES, TISSUE SAMPLES ARE NOT BEING RETRIEVED PROPERLY.".
Patient problems: Insufficient Information
MAUDE report 21894925 ↗InjuryApr 23, 2025Firing Problem; Firing Problem
REPORTER STATED, "THE TRIGGER MECHANISM IS NOW EXTREMELY STIFF, AND IN SOME CASES, TISSUE SAMPLES ARE NOT BEING RETRIEVED PROPERLY."
Patient problems: Insufficient Information
MAUDE report 21893394 ↗InjuryApr 23, 2025Firing Problem; Firing Problem
REPORTER STATED "THE TRIGGER MECHANISM IS NOW EXTREMELY STIFF, AND IN SOME CASES, TISSUE SAMPLES ARE NOT BEING RETRIEVED PROPERLY."
Patient problems: Insufficient Information
MAUDE report 21893189 ↗InjuryApr 23, 2025Firing Problem; Firing Problem
REPORTER STATED "THE TRIGGER MECHANISM IS NOW EXTREMELY STIFF, AND IN SOME CASES, TISSUE SAMPLES ARE NOT BEING RETRIEVED PROPERLY."
Patient problems: Insufficient Information
MAUDE report 21893124 ↗InjuryApr 23, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff
REPORTER STATED "THE TRIGGER MECHANISM IS NOW EXTREMELY STIFF, AND IN SOME CASES, TISSUE SAMPLES ARE NOT BEING RETRIEVED PROPERLY." MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 21892965 ↗InjuryApr 26, 2024Failure to Obtain Sample; Failure to Obtain Sample
IN CONNECTION WITH BIOPSY, THE BIOPSY NEEDLE BREAKS. IT IS DISCOVERED THEN, WE WILL PUT THE TISSUE SAMPLE ON MILLIPORE. THEN THE INNER PART IS COMPLETELY LOOSE AND WE CANNOT GET ANY TISSUE SAMPLE OUT OF THE "SLED". IF THERE IS ONE AT ALL. UPDATE: (TRANSLATED) FROM DANISH AGENCY. IN CONNECTION WITH ULTRASONICALLY GUIDED BIOPSY OF LIVER METASTASIS, THE INNER NEEDLE GOES ALL THE WAY OUT BY PUSHING IT INTO PLACE, THE INNER NEEDLE DOES NOT ENTER THE OUTER NEEDLE AS IT SHOULD (WHEN THE TISSUE SAMPLE FROM THE METASTASIS MUST BE SECURED ON MILLIPORE PAPER), BUT INTO THE FINGER OF THE DOCTOR . THE SPRING IN THE NEEDLE BROKE. HAS BEEN REPORTED AS AN INDUSTRIAL INJURY. IT FAILS TO GET THE TISSUE SAMPLE OUT. THEREFORE IT WAS NECESSARY TO TAKE A NEW BIOPSY FROM LIVER THE METASTASES, AT INCREASED RISK OF PATIENT.
Patient problems: Needle Stick/Puncture
MAUDE report 19189461 ↗MalfunctionApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A REPORTER INDICATED "CAME AWAY IN THE PATIENT MID PROCEDURE AFTER FIRING THE NEEDLE. WE MANAGE TO REMOVE THE CORE AND THEN USED ANOTHER NEEDLE TO TAKE MORE SAMPLES. THERE WAS NO HARM TO THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19185954 ↗MalfunctionFeb 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A FACILITY REPORTED THAT DURING A BONE BIOPSY PROCEDURE, THE NEEDLE BECAME TOTALLY DISCONNECTED FROM THE HUB DURING THE ACQUISITION OF A SAMPLE. THIS RESULTED IN A LARGE BLOOD SPRAY COVERING THE PHYSICIAN AND EQUIPMENT. THERE WAS NO PATIENT INJURY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18793159 ↗MalfunctionDec 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE PLEURA BIOPSY PROCEDURE, THE INTERVENTIONAL DOCTOR PRICKS THE LITTLE FINGER OF HIS RIGHT HAND WHEN THE NEEDLE IS DISASSEMBLED DURING THE PROCEDURE, CAUSING A BIOLOGICAL ACCIDENT."
Patient problems: Needle Stick/Puncture
MAUDE report 18253199 ↗MalfunctionOct 17, 2023Failure to Fire; Firing Problem; Failure to Fire; Firing Problem
WHEN RESETTING THE BIOPSY NEEDLE, THE HANDLE FAILED AT THE SPRING, MAKING IT IMPOSSIBLE TO REENGAGE THE NEEDLE TO PERFORM A SECOND BIOPSY. INCREASED DURATION OF THE PROCEDURE / PAIN FOR THE PATIENT.
Patient problems: Pain
MAUDE report 17949270 ↗MalfunctionSep 22, 2023Break; Break
THE NEEDLE SUPPORT BROKE, CAUSING DAMAGE TO THE PATIENT AND DISSATISFACTION FOR THE PHYSICIAN.
Patient problems: Insufficient Information
MAUDE report 17798309 ↗MalfunctionAug 17, 2023Break; Break
DESCRIBE THE EVENT OR PROBLEM: THE RADIOLOGIST WAS DOING A PROCEDURE ON THE PATIENT'S LEFT SHOULDER. WHEN SHE PULLED THE DEVICE FROM THE PATIENT AFTER TAKING A PASS CONTAINING A SPECIMEN THE DEVICE DISASSEMBLED FALLING APART IN THE RADIOLOGIST HANDS. SHE WAS ALMOST PUNCTURED WITH THE BLADE FROM THE DEVICE. DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE WAS HARD TO USE;
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17564607 ↗
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
- Tru-Core II Biopsy Instrument8 models · 13 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
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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