Quick-CoreRecalls & reported problems across all models
Cook Incorporated · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 129
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 7 models of Quick-Core by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 129 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2016 and Oct 11, 2023 — classified as 4 injuries, 125 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (102 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Quick-Core problems
Device problems
- Difficult to Remove102
- Device Operates Differently Than Expected7
- Separation Failure7
- Device Contaminated During Manufacture or Shipping4
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Device Operational Issue2
- Mechanical Problem2
Patient problems
- No Known Impact Or Consequence To Patient62
- No Patient Involvement28
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient14
- No Code Available3
- Hematoma2
- Fluid Discharge1
- No Information1
Quick-Core models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quick-Core G08790INSTRUMENT, BIOPSY83 reports
- Quick-Core G27017INSTRUMENT, BIOPSY17 reports
- Quick-Core G08728INSTRUMENT, BIOPSY13 reports
- Quick-Core G27016INSTRUMENT, BIOPSY11 reports
- Quick-Core G08788INSTRUMENT, BIOPSY2 reports
- Quick-Core G28292INSTRUMENT, BIOPSY2 reports
- Quick-Core G27018INSTRUMENT, BIOPSY1 report
Recent Quick-Core adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page