MARQUEE recallZ-0027-2024 · Bard Peripheral Vascular Inc · initiated Aug 10, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bard Peripheral Vascular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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]
Recall details
- Recall number
- Z-0027-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2023
- Posted by the FDA
- Oct 4, 2023
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 1,545
- Product code
- KNW
- FDA submissions
- K133948
- 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 description
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Code information (models, lots, serial numbers)
UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MARQUEE MQK2016Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY2 recalls28 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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