Z-0027-2024Class II

Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

Name: Z-0027-2024 Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Creator: Bard Peripheral Vascular Inc
Published: 2023-08-10
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2023-08-10 / Open, Classified / root cause: design

FDA source

Bard Peripheral Vascular Inc began a recall of Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 on 2023-08-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0027-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-10
Posted: 2023-10-04
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Product code: KNW Instrument, Biopsy
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On 8/10/23, BD mailed or emailed recall notices to Medical Directors, Risk Managers, Medical Device Safety Offices, Lab Managers, Clinical Engineers, and Distributors who were told to do the following: 1) Discontinue distribution and use and immediately dispose of all affected product. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. 3) Distributors, identify all customers within your distribution network that purchased any affected product and provide a copy of the customer letter to all customers and advise them of this field action notification on behalf of the recalling firm. 2) Complete the attached Response Form and return via email to: [email protected] If you require further assistance contact: the North American Regional Complaint Center: 1-844-8BD- LIFE (1-844-823-5433) M-F 8am - 5pm CT, or Email: [email protected]
Quantity in commerce: 1,545
Distribution: Worldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA, OR, AZ, NJ, NY, OH, NC, MD, MI, LA, IN, AK, TN and the countries of CA, AU, BE.
Product codes and lots: UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0027-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0027-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-04

Product code KNW

K133948Class IIBard(r) Monopty(r) Disposable Core Biopsy Instrument, Bard(r) Max-Core(r) Disposable Core InstrumentBard Peripheral Vascular, Inc. / cleared 2014-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)