Quick-Core G27017Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002270176), received between Jul 1, 2017 and Nov 30, 2021 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2021Difficult to Remove; Difficult to Remove

  THE COMPLAINT DEVICE WAS RECEIVED BY THE MANUFACTURER ON 03DEC2021. UPON PRELIMINARY INVESTIGATION, IT WAS FOUND THAT EITHER RUST OR BIOMATTER WERE PRESENT ON THE TROCAR STYLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894233 ↗
• MalfunctionNov 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS CHECKED PRIOR TO USE FOR AN UNKNOWN PROCEDURE. THE OPERATOR WAS UNABLE TO SEPARATE THE COAXIAL NEEDLE. A NEW, SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894108 ↗
• MalfunctionAug 11, 2021Difficult to Remove; Difficult to Remove

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309165 ↗
• MalfunctionAug 10, 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 10384034 ↗
• MalfunctionAug 7, 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 10379696 ↗
• MalfunctionApr 28, 2020Difficult to Remove; Difficult to Remove

  ADDITIONAL INFORMATION RECEIVED ON 01MAY2020 INDICATES THE FAILURE OCCURRED DURING A LIVER BIOPSY PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10006113 ↗
• MalfunctionNov 8, 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 Patient Involvement

  MAUDE report 9296930 ↗
• MalfunctionOct 21, 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 9213500 ↗
• MalfunctionSep 25, 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 9119025 ↗
• MalfunctionSep 9, 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 Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8977393 ↗
• MalfunctionAug 16, 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 Information

  MAUDE report 8902250 ↗
• MalfunctionJul 30, 2019Obstruction of Flow; Obstruction of Flow

  DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE PROCEDURE WAS TO TREAT AN ESOPHAGEAL ULCER BLEED. THE PHYSICIAN PLACED THE DEVICE IN PLACE BUT THE HEMOSPRAY WOULD NOT SPRAY. TROUBLESHOOTING TECHNIQUES WERE CARRIED OUT AND THE SECOND CATHETER WAS UTILIZED BUT THE DEVICE WOULD NOT SPRAY. ALTERNATE DEVICES WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PATIENT OUTCOME WAS GOOD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8843848 ↗
• MalfunctionMay 20, 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 8625171 ↗
• MalfunctionMay 2, 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 8574184 ↗
• MalfunctionMay 10, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS BEING TESTED DURING PRE-OP AND THE INTRODUCER WAS FAULTY. THE CAP ON THE INTRODUCER WAS UNABLE TO BE UNSCREWED; THEREFORE, THE NEEDLE COULD NOT BE PUT THROUGH. AS REPORTED, THIS OCCURRED PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7504479 ↗
• MalfunctionMar 5, 2018Difficult to Remove; Difficult to Remove

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN OPERATING THE QUICK-CORE COAXIAL BIOPSY NEEDLE SET, THE OPERATOR EXPERIENCED DIFFICULTY UNDOING THE STYLET OF THE DEVICE. THE USER HAD INTRODUCED THE NEEDLE AND GUIDED IT INTO POSITION FOR A BIOPSY UNDER COMPUTED TOMOGRAPHY IMAGING. WHEN THE USER ATTEMPTED TO REMOVE THE STYLET FROM THE NEEDLE TO PERFORM THE BIOPSY, THE STYLET WAS STUCK. THE USER WAS EVENTUALLY ABLE TO UNDO THE STYLET WITH THE HELP OF ARTERY FORCEPS, WHICH WERE GRIPPED FIRMLY TO ASSIST IN THE REMOVAL OF THE STYLET. THE CUSTOMER CONFIRMED THAT THE PRODUCT PROBLEM DID NOT NECESSITATE ANY ADDITIONAL PROCEDURES, AND NO PATIENT ADVERSE EVENTS RESULTED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7312942 ↗
• MalfunctionJul 1, 2017Difficult to Remove; Difficult to Remove

  CUSTOMER REPORTED OPENING AN UNUSED QUICK-CORE COAXIAL BIOPSY NEEDLE SET TO EVALUATE FOR EASE OF USE. THE CUSTOMER REPORTED THAT THE STYLET IS "EXTREMELY DIFFICULT TO GET IT OUT." THERE WAS NO PATIENT CONTACT, ACCORDINGLY NO ADVERSE PATIENT CONSEQUENCE. THE DEVICE IS ANTICIPATED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6683456 ↗