MARQUEE MQK1820Recalls & reported problems

Bard Peripheral Vascular, Inc. · MARQUEE® Disposable Core Biopsy Instrument Kit, 18g x 20cm · Class 2

All models of MARQUEE (26)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

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 · Recall details · FDA record ↗

Device details

UDI-DI	`00801741097362`
Brand	MARQUEE
Model	MQK1820
Company	Bard Peripheral Vascular, Inc.
Product code	KNW · INSTRUMENT, BIOPSY
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 21, 2025

Device type (GMDN): Side-notch biopsy gun handpiece/needle

A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.

Other INSTRUMENT, BIOPSY devices

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1 recall4,258 reports
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MAX-CORE MC1820
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1 recall2,404 reports
MAX-CORE MC1816
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall1 death848 reports
MAX-CORE MC1410
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1 recall399 reports
MAX-CORE MC1610
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1 recall394 reports
ENCOR® ECP0110GV
Senorx, Inc. · INSTRUMENT, BIOPSY
392 reports
ENCOR® ECP0110G
Senorx, Inc. · INSTRUMENT, BIOPSY
390 reports

All INSTRUMENT, BIOPSY devices →

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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