Quick-Core G08790Recalls & reported problems
Cook Incorporated · Quick-Core, Biopsy Needle Set · Class 2
Quick summary
This is a Cook Quick-Core biopsy needle set. Most of the 83 reports describe needle parts that are difficult to remove or unscrew, sometimes requiring tools, and some led to a replacement needle being used. There are 4 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00827002087903), received between Nov 14, 2016 and Oct 11, 2023 — classified as 4 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (68 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove68
- Device Operates Differently Than Expected5
- Device Contaminated During Manufacture or Shipping4
- Adverse Event Without Identified Device or Use Problem2
- Separation Failure2
- Device Operational Issue1
- Mechanical Jam1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient40
- No Patient Involvement18
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient8
- Hematoma2
- No Code Available2
- Fluid Discharge1
Recent adverse event reports
The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2023Difficult 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 17916512 ↗MalfunctionSep 8, 2022Difficult to Remove; Difficult to Remove
IN ADDITIONAL INFORMATION RECEIVED ON 15SEP2022, IT WAS CONFIRMED THAT THE ISSUE WAS WITH THE COAXIAL INTRODUCER NEEDLE. CONTACT WITH THE PATIENT WAS MADE. AFTER THE BIOPSY CANNULA WAS INSERTED INTO THE PATIENT, IT WAS FOUND THAT THE NEEDLE CORE COULD NOT BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15384204 ↗MalfunctionJul 27, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THE NEEDLE ASSEMBLY OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS UNABLE TO BE UNSCREWED PRIOR TO A LUNG PUNCTURE PROCEDURE THAT OCCURRED (B)(6) 2022. THE USER HAD TO USE TOOLS TO UNSCREW THE TROCAR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW LIKE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15113604 ↗MalfunctionJul 27, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED WHEN ATTEMPTING TO REMOVE THE TROCAR FROM A QUICK-CORE COAXIAL BIOPSY NEEDLE SET PRIOR TO A SUPRACLAVICULAR LYMPH NODE PUNCTURE ON (B)(6) 2022. THE PUNCTURE NEEDLE WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15113450 ↗MalfunctionJul 27, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THE NEEDLE ASSEMBLY OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS UNABLE TO BE UNSCREWED PRIOR TO A LUNG PUNCTURE PROCEDURE THAT OCCURRED ON (B)(6) 2022. THE USER HAD TO USE TOOLS TO UNSCREW THE TROCAR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW, LIKE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15113328 ↗MalfunctionJun 1, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED A MALE PATIENT REQUIRED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET FOR A PERCUTANEOUS LUNG BIOPSY PROCEDURE. PRIOR TO PATIENT CONTACT, THE INNER STYLET WAS DIFFICULT TO REMOVE FROM THE COAXIAL NEEDLE. ANOTHER SIMILAR DEVICE WAS USED INSTEAD TO SUCCESSFULLY 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 14565639 ↗MalfunctionJan 26, 2022Difficult to Remove; Difficult to Remove
PRIOR TO PATIENT CONTACT, IT WAS DISCOVERED THAT THE STYLET OF THE COOK QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS SCREWED TOO TIGHT IN THE OUTER PART OF THE NEEDLE AND WAS UNABLE TO BE TAKEN APART. ANOTHER 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 13361300 ↗MalfunctionOct 1, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE INNER STYLETS OF TWO QUICK-CORE COAXIAL BIOPSY NEEDLE SETS COULD NOT BE REMOVED FROM THE COAXIAL NEEDLES. THIS OCCURRED PRIOR TO PATIENT CONTACT. THE DEVICES WERE INTENDED TO BE USED FOR A NEEDLE BIOPSY IN THE PATIENT'S LIVER. THE FIRST TWO DEVICES THE USER ATTEMPTED TO USE EXPERIENCED THIS ISSUE, SO A THIRD WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12560491 ↗MalfunctionSep 28, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE INNER STYLET OF A QUICK-CORE COAXIAL BIOPSY NEEDLE SET COULD NOT BE REMOVED FROM THE COAXIAL NEEDLE. THIS OCCURRED PRIOR TO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12540636 ↗MalfunctionSep 24, 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 12529534 ↗MalfunctionAug 3, 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 12266560 ↗MalfunctionJul 30, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET WAS REQUIRED FOR AN UNKNOWN PROCEDURE. PRIOR TO PATIENT CONTACT, THE STYLET WAS SCREWED TOO TIGHT IN THE OUTER PART OF THE NEEDLE AND COULD NOT BE SEPARATED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. 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 12256505 ↗MalfunctionJul 16, 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 12181106 ↗MalfunctionJun 10, 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 11975193 ↗MalfunctionApr 20, 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: Fluid Discharge
MAUDE report 11697570 ↗MalfunctionFeb 22, 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 Consequences Or Impact To Patient
MAUDE report 11361727 ↗MalfunctionDec 21, 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 Patient Involvement
MAUDE report 11049645 ↗MalfunctionDec 15, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET FOR AN UNKNOWN PROCEDURE. PRIOR TO PATIENT CONTACT, THE OPERATOR COULD NOT SEPARATE THE STYLET FROM THE OUTER PART OF THE NEEDLE. 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 11012817 ↗MalfunctionNov 6, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED A MALE PATIENT REQUIRED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET FOR A LUNG BIOPSY PROCEDURE. PRIOR TO PATIENT CONTACT, THE STYLET COULD NOT BE SEPARATED FROM THE NEEDLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10802726 ↗MalfunctionNov 3, 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 Consequences Or Impact To Patient
MAUDE report 10777898 ↗MalfunctionOct 23, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET FOR AN UNKNOWN PROCEDURE. PRIOR TO PATIENT CONTACT, THE OPERATOR NOTED THE STYLET WAS SCREWED TOO TIGHT IN THE OUTER PART OF THE NEEDLE AND COULD NOT BE TAKEN APART. 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 10729445 ↗MalfunctionOct 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 Consequences Or Impact To Patient
MAUDE report 10729276 ↗MalfunctionOct 23, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED A MALE PATIENT REQUIRED A QUICK-CORE COAXIAL BIOPSY NEEDLE SET FOR A PUNCTURE BIOPSY OF A LUNG TUMOR. PRIOR TO PATIENT CONTACT, THE OPERATOR NOTED THE STYLET WAS SCREWED TOO TIGHT IN THE OUTER PART OF THE NEEDLE AND COULD NOT BE TAKEN APART. THIS FAILURE OCCURRED TWO MORE TIMES. A FOURTH DEVICE WAS USED TO SUCCESSFULLY 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 Consequences Or Impact To Patient
MAUDE report 10729229 ↗MalfunctionSep 29, 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 10599884 ↗MalfunctionSep 29, 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 10599780 ↗
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- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.