MARQUEE MQK2016Recalls & reported problems
Bard Peripheral Vascular, Inc. · MARQUEE® Disposable Core Biopsy Instrument Kit, 20g x 16cm · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Bard Marquee disposable core biopsy kit takes tissue samples through a needle during procedures. The 28 reports mostly describe the needle not fitting or getting stuck in the kit's coaxial introducer, sometimes requiring another device to finish; 2 mention a collapsed lung and there were no deaths. Two recalls name this device: an open one from August 2023 over a diameter mismatch between cannula and needle that can block reaching target tissue, and a closed one from January 2021 because the penetration depth switch detached during use.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741097393), received between May 10, 2023 and Mar 4, 2024 — classified as 2 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (27 reports).
2 FDA recall records name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 10, 2023Open, Classified
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.
Z-0027-2024 · Root cause: Device Design · FDA record ↗
- Jan 14, 2021Terminated
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Z-1289-2021 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Device-Device Incompatibility27
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Pneumothorax2
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE AND THE TROCAR IN THE KIT ALLEGEDLY HAD THE SAME DIAMETER AS THE BIOPSY NEEDLE ITSELF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18825024 ↗MalfunctionMar 4, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE NEEDLE AND THE TROCAR IN THE KIT ALLEGEDLY HAD THE SAME DIAMETER AS THE BIOPSY NEEDLE ITSELF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18824962 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE NEEDLE ALLEGEDLY WOULD NOT PASS THROUGH THE COAXIAL INTRODUCER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610760 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY GOT STUCK AND DID NOT FIT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610667 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY GOT STUCK AND DID NOT FIT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610666 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY GOT STUCK AND DID NOT FIT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610663 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY GOT STUCK AND DID NOT FIT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610578 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY GOT STUCK AND DID NOT FIT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610576 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY GOT STUCK AND DID NOT FIT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610575 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY GOT STUCK AND DID NOT FIT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610508 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DOES NOT FIT INTO THE COAXIAL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610425 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DOES NOT FIT INTO THE COAXIAL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610420 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DOES NOT FIT INTO THE COAXIAL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610419 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY DOES NOT FIT INTO THE COAXIAL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610351 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610013 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610012 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610011 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610010 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610009 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610008 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610007 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17610006 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17609961 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17609922 ↗MalfunctionAug 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE INVESTIGATIONS OF THE LOT SAMPLES, THE COAXIAL OF THE DEVICE WAS IDENTIFIED TO BE NOT INCOMPATIBLE WITH THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17609908 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.