MARQUEE recallZ-0467-2025 · Bard Peripheral Vascular Inc · initiated Sep 30, 2024

Why it was recalled

Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.

FDA root cause category: Process change control

What the company is doing

On 9/30/24, removal notices were sent to customers who were asked to do the following: 1) Discontinue use of product listed in the letter, and immediately dispose of all affected product remaining in your possession in accordance with your local facility s process. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, please share this notice to ensure that these entities are contacted and informed of the recall. 3) Complete and return the response form via email to [email protected] - If you purchased this product from a distributor, contact your distributor for further instructions and resolution. - Affected lots distributed from 05 April 2023 through 23 Aug 2024. If further assistance is required contact the firm: - North American Regional Complaint Center: 1-844-823-5433, Mon - Fri 8:00am and 5:00pm CT, [email protected] - Recall Related Questions: [email protected] On 1/15/2025, additional removal notices were mailed or emailed to distributors informing them of additional affected devices.

Recall details

Recall number

Z-0467-2025

Status

Open, Classified

Initiated by the company

Sep 30, 2024

Posted by the FDA

Nov 15, 2024

Recalling firm

Bard Peripheral Vascular Inc

Quantity

71,498

Product code

KNW

FDA submissions

K133948

Distribution

Worldwide - US Nationwide including in the states of WA, LA, MN, PA, UT, SC, OK, KY, AZ, IL, TX, NJ, NY, FL, TN, IN, OH, NC, CO, VA, GA, MD, CA, AL, WI, MO, IA, CT, NE, MI, MS, NV, KS, OR, SD, ID, NH, RI, WY, AR, MA, DE, ND, NM, AK, PR and the countries of Portugal, Spain, South Africa, Greece, United Arab Emirates, United Kingdom, Sweden, Finland, Belgium, Korea, Australia, Canada.

Product description

Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

• MARQUEE MQK1210

  Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
  2 recalls11 reports
• MARQUEE MQ1210

  Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
  2 recalls9 reports
• MARQUEE MQK1213

  Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
  2 recalls1 report
• MARQUEE MQ1213

  Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
  2 recalls0 reports

Product lines

• MARQUEEBard Peripheral Vascular, Inc. · 26 models · 219 reports · 3 recalls