Quick-Core G27016Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002270169), received between Jan 17, 2019 and Sep 14, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2021Difficult to Remove; Difficult to Remove

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468417 ↗
• MalfunctionMar 23, 2020Difficult to Remove; Difficult to Remove

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9864652 ↗
• MalfunctionJul 15, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS TO BE USED ON A FEMALE PATIENT FOR A BREAST AND LUNG BIOPSY. PRIOR TO PATIENT CONTACT, IT WAS REPORTED THE COAXIAL NEEDLE WAS JAMMED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 8790655 ↗
• MalfunctionMay 8, 2019Mechanical Problem; Mechanical Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8590435 ↗
• MalfunctionApr 22, 2019Difficult to Remove; Difficult to Remove

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8536603 ↗
• MalfunctionFeb 5, 2019Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8306983 ↗
• MalfunctionFeb 5, 2019Difficult to Remove; Difficult to Remove

  IT WAS ORIGINALLY REPORTED THAT THE INTERNATIONAL CUSTOMER WAS UNABLE TO START USING THE NEEDLES WITHOUT USING WHAT WAS BELIEVED TO BE AN INORDINATE AMOUNT OF FORCE. AFTER THE APPLICATION OF THIS FORCE, THE COMPLAINT DEVICE WAS DEPLOYED AND THE PROCEDURES WERE SUCCESSFULLY COMPLETED. IT WAS DISCOVERED DURING THE INVESTIGATION PORTION OF THE EVALUATION OF THIS INCIDENT THAT THE FAILURE MODE AS REPORTED BY THE CUSTOMER LIKELY DESCRIBES A DIFFICULTY IN SEPARATING THE NEEDLE AND THE CANNULA.

  Patient problems: No Patient Involvement

  MAUDE report 8305108 ↗
• MalfunctionJan 17, 2019Separation Failure; Separation Failure

  IT WAS REPORTED THE INNER STYLET WAS JAMMED IN THE COAXIAL NEEDLE FROM A QUICK-CORE COAXIAL BIOPSY NEEDLE SET BEFORE A LUNG BIOPSY PROCEDURE. THE CANNULA WAS FOUND NOT TO SEPARATE FROM THE NEEDLE PRIOR TO THE PROCEDURE AND THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER QUICK-CORE COAXIAL BIOPSY NEEDLE SET. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8258111 ↗
• MalfunctionJan 17, 2019Separation Failure; Separation Failure

  IT WAS REPORTED THE INNER STYLET WAS JAMMED IN THE COAXIAL NEEDLE FROM A QUICK-CORE COAXIAL BIOPSY NEEDLE SET BEFORE A BREAST BIOPSY PROCEDURE. THE CANNULA WAS FOUND NOT TO SEPARATE FROM THE NEEDLE PRIOR TO THE PROCEDURE AND THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER QUICK-CORE COAXIAL BIOPSY NEEDLE SET. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8258100 ↗
• MalfunctionJan 17, 2019Separation Failure; Separation Failure

  IT WAS REPORTED THE CO-AXIAL OF CANNULAS FROM TWO QUICK-CORE COAXIAL BIOPSY NEEDLE SETS BEFORE A BREAST BIOPSY PROCEDURE. THE FIRST CANNULA WAS FOUND NOT TO SEPARATE FROM THE NEEDLE PRIOR TO THE PROCEDURE AND THE DEVICE DID NOT MAKE PATIENT CONTACT. THIS SEPARATION FAILURE IS RECORDED UNDER MEDWATCH REPORT #1820334-2019-00089. THE SECOND SET USED EXPERIENCED THE SAME PROBLEM IN WHICH THE CANNULA WOULD NOT SEPARATE FROM THE NEEDLE PRIOR TO PATIENT CONTACT. THIS SECOND MALFUNCTION IS RECORDED UNDER THIS MEDWATCH REPORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER QUICK-CORE COAXIAL BIOPSY NEEDLE SET. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257865 ↗
• MalfunctionJan 17, 2019Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE CO-AXIAL OF CANNULAS FROM TWO QUICK-CORE COAXIAL BIOPSY NEEDLE SETS JAMMED BEFORE A BREAST BIOPSY PROCEDURE. THE FIRST CANNULA WAS FOUND NOT TO SEPARATE FROM THE NEEDLE PRIOR TO THE PROCEDURE AND THE DEVICE DID NOT MAKE PATIENT CONTACT. THIS SEPARATION FAILURE IS RECORDED UNDER THIS MEDWATCH REPORT. THE SECOND SET USED EXPERIENCED THE SAME PROBLEM IN WHICH THE CANNULA WOULD NOT SEPARATE FROM THE NEEDLE PRIOR TO PATIENT CONTACT. THIS SECOND MALFUNCTION IS RECORDED UNDER MEDWATCH REPORT #1820334-2019-00090. THE PROCEDURE WAS COMPLETED WITH ANOTHER QUICK-CORE COAXIAL BIOPSY NEEDLE SET. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257756 ↗