SuperCore™ Biopsy Instrument 701118150Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00886333005888), received between Jul 15, 2021 and Jan 28, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (4 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 12 most recent of 12 reports, 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 ↗
• 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 ↗
• MalfunctionDec 12, 2022Detachment of Device or Device Component

  THE SHELL OF BIOPSY NEEDLE FALLS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959783 ↗
• MalfunctionAug 15, 2022Break; Nonstandard Device; Detachment of Device or Device Component

  AFTER THE DEVICE WAS FIRED IN THE TARGET AREA, WHEN ATTEMPTED TO EXPOSE THE SPECIMEN NOTCH TO COLLECT BIOPSY SAMPLE, THE HOUSING BROKE AND THE PLUNGER DETACHED FROM THE HOUSING. EVEN THOUGH IT WAS A VERY DANGEROUS SITUATION FOR THE PATIENT AND THE DOCTOR, FORTUNATELY IT DID NOT HARM ANYONE. SUGAN CHECK OF THE RETURNED UNIT: THE HOUSING OF THE RETURNED DEVICE WAS OPENED. THE SNAP FIT LATCH TABS WERE NOT BROKEN, HOWEVER, THERE SEEMED FLASH ON THE GOOSE NECK PORTION OF THE LATCH TAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15228218 ↗
• MalfunctionJun 27, 2022Break; Nonstandard Device

  CUSTOMER REPORT: TODAY THERE WAS A SITUATION DURING THE PROCEDURE, DR (B)(6) WHEN USING THE SEMI AUTOMATIC BIOPSY NEEDLE 18GAX15CM. WHEN SETTING THE NEEDLE AND PULLING OUT THE DRAWER, THE NEEDLE BROKE AND PIERCED THE DOCTOR'S. CAN YOU CHECK IF IT'S A PROBLEM WITH ALL BATCHES? VERY SERIOUS WHAT HAPPENED."

  Patient problems: Needle Stick/Puncture

  MAUDE report 14834502 ↗
• MalfunctionJul 15, 2021Improper or Incorrect Procedure or Method; Separation Problem

  PATIENT: INFECTIOUS DISEASE PATIENT, PYOGENIC SPONDYLITIS EVENT DESCRIPTION: THE DEVICE WAS OPENED FOR A SPINE BIOPSY PROCEDURE. THE SUPERCORE WAS TEST FIRED ONCE. THEN THE NEEDLE WAS INSERTED INTO THE PATIENT, HOWEVER, THE PHYSICIAN NOTICED THAT HE HAD FORGOT TO LOCK THE PLUNGER IN READY POSITION. THE NEEDLE WAS REMOVED AND WHEN THE PLUNGER WAS PULLED TO LOCK, WITH NORMAL FORCE, THE PLUNGER CAME OFF THE HOUSING WITH THE STYLET NEEDLE AND SEPARATED. AT THAT TIME BY THE UNPREDICTABLE MOVEMENT, THE PHYSICIAN GOT PRICKED HIS LEFT PALM WITH THE SEPARATED STYLET NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12175898 ↗