Bard Peripheral Vascular Inc: Marquee Disposable Core Biopsy Instrument Kits Recalled for Needle Mismatch

Agency Publication Date: October 4, 2023

Summary

Bard Peripheral Vascular Inc. is recalling 1,545 units of the Bard Marquee Disposable Core Biopsy Instrument Kit (Model MQK2016) because of a manufacturing defect where the needle components do not fit together properly. Specifically, the inner diameter of the coaxial cannula is too small, which prevents the biopsy cutting needle from passing through to reach the target tissue. This defect can lead to failed biopsies, necessitating repeat medical procedures for the patient.

Risk

If the biopsy needle cannot access the target tissue, patients may experience procedural complications including pain, discomfort, bleeding, or a collapsed lung (pneumothorax), in addition to the risks associated with undergoing a repeated medical procedure.

What You Should Do

Identify if you have the affected medical device by checking the packaging for the Product Reference MQK2016 and UDI-DI 00801741097393.
Specifically look for Lot Number 0001480774 with an expiration date of 07/28/2025.
Stop using the affected biopsy kits immediately and quarantine them to prevent accidental use in clinical procedures.
Contact your healthcare provider or Bard Peripheral Vascular Inc. at 1-888-463-6332 for specific instructions regarding the return or replacement of these kits.
Healthcare professionals should evaluate if any previous procedures using this lot were impacted by the mismatch issue.
For additional information or to report adverse events, contact the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Device Quarantine

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Bard Marquee Disposable Core Biopsy Instrument Kit

Model / REF:

MQK2016

Z-0027-2024

UPC Codes:

00801741097393

Lot Numbers:

0001480774

Date Ranges: 07/28/2025 (Expiration)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92994

Status: Active

Manufacturer: Bard Peripheral Vascular Inc

Sold By: Medical distributors; Direct to hospitals

Manufactured In: United States

Units Affected: 1,545

Distributed To: Puerto Rico, Colorado, Texas, California, Washington, Oregon, Arizona, New Jersey, New York, Ohio, North Carolina, Maryland, Michigan, Louisiana, Indiana, Alaska, Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected medical device by checking the packaging for the Product Reference MQK2016 and UDI-DI 00801741097393.

Specifically look for Lot Number 0001480774 with an expiration date of 07/28/2025.

Stop using the affected biopsy kits immediately and quarantine them to prevent accidental use in clinical procedures.

Contact your healthcare provider or Bard Peripheral Vascular Inc. at 1-888-463-6332 for specific instructions regarding the return or replacement of these kits.

Healthcare professionals should evaluate if any previous procedures using this lot were impacted by the mismatch issue.

For additional information or to report adverse events, contact the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls.