FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
- Recall number
- Z-0027-2024
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
- Status
- Open, Classified
- Initiated
- 2023-08-10
- Posted
- 2023-10-04
- Terminated
- not on file
- Reason
- 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
- 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: BDRC45@bd.com 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: productcomplaints@bd.com
- Quantity
- 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.
- Lot, serial or model codes
- UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025
- 510(k) numbers
- ["K133948"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28