Quick-Core G08788Recalls & reported problems
Cook Incorporated · Quick-Core, Biopsy Needle Set · Class 2
All models of Quick-Core (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002087880), received between Oct 26, 2017 and Jul 15, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Difficult to Remove2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 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 8789473 ↗MalfunctionOct 26, 2017Difficult to Remove; Difficult to Remove
THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN USED, THE QUICK-CORE COAXIAL BIOPSY NEEDLE WOULD NOT PULL OUT FROM THE CANNULA. THIS ISSUE OCCURRED WITH TWO SEPARATE DEVICES. THE PROCEDURE WAS ULTIMATELY TRUNCATED WHEN THE PATIENT DEVELOPED A PNEUMOTHORAX. THE OPERATOR OF THE DEVICE REPORTED THAT THE CAUSE OF THE PNEUMOTHORAX IS NOT KNOWN. APPROXIMATELY 30 MINUTES LATER, THE PATIENT REPORTEDLY RETURNED TO THE WARD IN STABLE CONDITION. THE PATIENT IS CURRENTLY IN GOOD CONDITION. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT CURRENT NO MORE INFORMATION IS AVAILABLE. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE LEADING UP TO THE PRODUCT ISSUE AND SUBSEQUENT PNEUMOTHORAX WERE NOT REPORTED. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6980299 ↗
Other INSTRUMENT, BIOPSY devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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