Quick-Core G08728Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002087286), received between Oct 4, 2017 and Sep 13, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2021Difficult to Remove; Difficult to Remove

  THE PATIENT WAS IN THE CT SCANNER AS THE PHYSICIAN CHECKED THAT THE COAXIAL PARTS ALL CAME APART BEFORE PLACING THE INTRODUCER INTO THE PATIENT. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER BIOPSY NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460159 ↗
• MalfunctionSep 10, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE INNER STYLET OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS DIFFICULT TO REMOVE FROM THE COAXIAL NEEDLE. THIS OCCURRED PRIOR TO PATIENT CONTACT. 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 12455089 ↗
• MalfunctionAug 28, 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 10468476 ↗
• MalfunctionJul 8, 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 10247503 ↗
• MalfunctionJun 18, 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 10167191 ↗
• MalfunctionJan 27, 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 9633872 ↗
• 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 9296961 ↗
• 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 Known Impact Or Consequence To Patient

  MAUDE report 8900640 ↗
• 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 8790683 ↗
• 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 8304919 ↗
• MalfunctionFeb 4, 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 8301967 ↗
• MalfunctionOct 26, 2017Difficult to Remove; Difficult to Remove

  THE INTERNATIONAL CUSTOMER CONFIRMED THAT, WHEN THE QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS OPENED IN PREPARATION FOR A LUNG BIOPSY, THE OPERATOR CONFIRMED THAT THE INTERNAL COAXIAL NEEDLE COULD NOT BE REMOVED. THE DEVICE WAS EXCHANGED FOR ANOTHER ONE. NO ADDITIONAL PROCEDURES WERE REPORTEDLY REQUIRED; ADDITIONALLY, NO PATIENT ADVERSE EVENTS OR ADDITIONAL PRODUCT PROBLEMS WERE REPORTED. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6980334 ↗
• MalfunctionOct 4, 2017Device Operational Issue; Device Operational Issue

  THE INTERNATIONAL CUSTOMER REPORTED THAT, PRIOR TO PATIENT CONTACT, THE NEEDLE IN THE QUICK-CORE COAXIAL BIOPSY NEEDLE SET WOULD NOT PULL OUT OF THE CANNULA. THE OPERATOR EMPLOYED ANOTHER NEW DEVICE TO FINISH THE PROCEDURE SUCCESSFULLY, WITH NOT FURTHER COMPLICATIONS REPORTED. THE CUSTOMER CONFIRMED THAT NO ADVERSE EFFECTS OCCURRED AS A RESULT OF THE PRODUCT ISSUE. THE PRODUCT WAS RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Patient Involvement

  MAUDE report 6914357 ↗