MISSION recallZ-1564-2023 · Bard Peripheral Vascular Inc · initiated Apr 11, 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
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
FDA root cause category: Mixed-up of materials/components
What the company is doing
On 04/11/23 recall notices were distributed to customers who were asked to do the following: 1. Discontinue use and dispose of 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. If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution or replacement product. 4. Complete and return the Customer Response Form to [email protected] In addition, distributors were asked to do the following: Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification. If you require further assistance please contact: North American Regional Complaint Center, Phone: 1-844-8BD- LIFE (1-844-823-5433), say "Recall" when prompted, M-F 8am - 5pm CT, or email: [email protected]
Recall details
- Recall number
- Z-1564-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 11, 2023
- Posted by the FDA
- May 5, 2023
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 4,120
- Product code
- KNW
- FDA submissions
- K171953
- Distribution
- US Nationwide Distribution: PR, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY . OUS: BE, CA, AU
Product description
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Code information (models, lots, serial numbers)
REF/UDI-DI/Lot (Expiration Date): 2010MSK/00801741097089/0001445946(11/28/2024), 2016MSK/00801741097096/1458844(02/28/2025)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- MISSION 2016MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY2 recalls38 reports
- MISSION 2010MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY2 recalls13 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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