MISSION recallZ-0643-2024 · Bard Peripheral Vascular Inc · initiated Nov 8, 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
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
FDA root cause category: Process control
What the company is doing
On 11/8/23, recall notices were distributed to customers and distributors who were asked to do the following: 1) Discontinue use of affected product, 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 recall. If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution. - Distributors were asked to 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 expanded field action notification. 3) Complete and return the attached Customer Response Form via email to [email protected] Customers requiring additional assistance can contact the firm's North American Regional Complaint Center by phone: 1-844-823-5433, say "recall" when prompted M-F 8am - 5pm CT, or via email: [email protected]
Recall details
- Recall number
- Z-0643-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 8, 2023
- Posted by the FDA
- Jan 5, 2024
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 1,243,937
- Product code
- KNW
- FDA submissions
- K171953
- Distribution
- Worldwide - US Nationwide distribution including in the states of PR, IL, MA, GA, KY, CA, TX, PA, IA, MN, NH, MD, FL, ID, IN, AL, VA, CO, WI, NY, NV, OK, OH, WA, MI, MS, AZ, HI, SD, NJ, NE, MT, NC, DC, CT, WY, UT, TN, LA, NM, SC, VT, MO, ME, AR, OR, KS, RI, AK, WV, DE, ND, PR, GU and the countries of CA, BE, AU, KR, SG, CN, TH, HK, VI, VN, AR, JP, CL, IN, TW, CO, MX, DO, BR, BD, MM, PK, NP, PA.
Product description
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G x 25CM; 2010MSK/ Mission Kit 20G x 10CM; 2016MSK/ Mission Kit 20G x 16CM; 2020MSK/ Mission Kit 20G x 20CM
Code information (models, lots, serial numbers)
Show the full code information (16k characters)
REF/UDI-DI/Lot (Expiration Date): 1410MSK/ 00801741142543/ 0001418630(05/28/24), 0001429851(07/28/24), 0001433778(08/28/24), 0001441794(10/28/24), 0001443076(10/28/24, 0001446454(11/28/24, 0001451131(01/28/25, 0001452840(01/28/25, 0001463142(03/28/25, 0001468867(04/28/25, 0001475757(06/28/25, 0001481508(07/28/25, 0001485193(08/28/25, 0001487094(08/28/25, 0001488512(08/28/25, 0001491080(09/28/25, 0001491583(09/28/25, 0001498859(11/28/25, 0001502349(12/28/25); 1416MSK/ 00801741142550/0001402196(01/28/24), 0001423061(06/28/24), 0001430525(07/28/24), 0001434059(08/28/24), 0001435619(09/28/24), 0001452376(01/28/25), 0001458437(02/28/25), 0001464693(03/28/25), 0001464694(03/28/25); 1610MSK/ 00801741142567/0001390419(10/28/23), 0001392740(10/28/23), 0001402197(01/28/24), 0001415815(04/28/24), 0001418632(05/28/24), 0001426735(06/28/24), 0001426839(07/28/24), 0001430408(07/28/24), 0001430528(07/28/24), 0001433779(08/28/24), 0001468480(04/28/25), 0001468479(04/28/25), 0001474221(05/28/25), 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0001448748(12/28/24)0001449432(12/28/24), 0001449433(12/28/24), 0001456597(02/28/25), 0001456153(02/28/25), 0001456573(02/28/25), 0001456936(02/28/25), 0001456596(02/28/25),0001459554(02/28/25),0001461729(03/28/25), 0001461728(03/28/25), 0001462125(03/28/25), 0001475009(05/28/25), 0001475008(05/28/25), 0001478968(06/28/25), 0001478963(06/28/25), 0001479643(06/28/25), 0001479644(06/28/25), 0001482928(07/28/25), 0001482931(07/28/25), 0001482930(07/28/25), 0001482932(07/28/25), 0001482929(07/28/25), 0001482934(07/28/25), 0001488082(08/28/25), 0001487710(08/28/25), 0001487711(08/28/25), 0001487602(08/28/25), 0001488510(08/28/25), 0001488081(08/28/25), 0001490705(09/28/25), 0001490708(09/28/25), 0001490706(09/28/25), 0001498139(11/28/25), 0001498140(11/28/25), 0001503043(12/28/25), 0001503044(12/28/25), 0001504002(12/28/25), 0001503958(12/28/25), 0001445946(11/28/24); 2016MSK/ 00801741097096/0001390417(10/28/23), 0001390418(10/28/23), 0001392738(10/28/23), 0001394806(11/28/23), 0001395410(11/28/23), 0001398980(12/28/23), 0001398979(12/28/23), 0001401523(12/28/23), 0001401520(12/28/23), 0001402087(01/28/24), 0001402086(01/28/24), 0001415824(04/28/24), 0001415826(04/28/24), 0001418627(05/28/24), 0001418628(05/28/24), 0001423816(06/28/24), 0001423815(06/28/24), 0001428803(07/28/24), 0001428592(07/28/24), 0001429954(07/28/24), 0001430089(07/28/24), 0001430339(07/28/24), 0001432740(08/28/24), 0001432739(08/28/24), 0001434756(08/28/24), 0001437864(09/28/24), 0001441795(10/28/24), 0001441796(10/28/24), 0001442314(10/28/24), 0001442315(10/28/24), 0001442313(10/28/24), 0001442312(10/28/24), 0001445803(11/28/24), 0001445944(11/28/24), 0001445802(11/28/24), 0001445801(11/28/24), 0001448753(12/28/24), 0001448752(12/28/24),0001450642(12/28/24), 0001450646(12/28/24), 0001450644(12/28/24), 0001453528(01/28/25), 0001453530(01/28/25), 0001453529(01/28/25), 0001454098(01/28/25), 0001456155(02/28/25), 0001456154(02/28/25), 0001457603(02/28/25), 0001457602(02/28/25), 0001458843(02/28/25), 0001469201(04/28/25), 0001469202(04/28/25), 0001469200(04/28/25), 0001469577(04/28/25), 0001475585(05/28/25), 0001475411(05/28/25), 0001475410(05/28/25), 0001475412(05/28/25), 0001476363(06/28/25), 0001476364(06/28/25), 0001478962(06/28/25), 0001478961(06/28/25), 0001480801(07/28/25), 0001483581(07/28/25), 0001483582(07/28/25), 0001486538(08/28/25), 0001487713(08/28/25), 0001486539(08/28/25), 0001489271(08/28/25), 0001489612(08/28/25), 0001487714(08/28/25), 0001492480(09/28/25), 0001492475(09/28/25), 0001492477(09/28/25), 0001492478(09/28/25), 0001492479(09/28/25), 0001492476(09/28/25), 0001495451(10/28/25), 0001497095(10/28/25), 0001497094(10/28/25), 0001497674(10/28/25), 0001497354(10/28/25), 0001498772(11/28/25), 0001499753(11/28/25), 0001499751(11/28/25), 0001499752(11/28/25), 0001500387(11/28/25), 0001503045(12/28/25), 0001503830(12/28/25), 0001503828(12/28/25), 0001503046(12/28/25), 0001503829(12/28/25), 0001458844(02/28/25); 2020MSK/ 00801741097102/0001412035(03/28/24), 0001414700(04/28/24), 0001415128(04/28/24), 0001422837(06/28/24), 0001425299(06/28/24), 0001425389(06/28/24), 0001435087(09/28/24), 0001439257(10/28/24), 0001443304(11/28/24), 0001451614(01/28/25), 0001463280(03/28/25), 0001464594(03/28/25), 0001469727(04/28/25), 0001469431(04/28/25), 0001469767(04/28/25), 0001469768(04/28/25), 0001471378(05/28/25), 0001487723(08/28/25), 0001491546(09/28/25), 0001492487(09/28/25), 0001494059(09/28/25), 0001499269(11/28/25), 0001504259(12/28/25)
Devices named in this recall
11 devices in the FDA device registry whose identifier appears in the recall's code information.
- MISSION 1816MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY2 recalls1 death41 reports
- MISSION 2016MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY2 recalls38 reports
- MISSION 2010MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY2 recalls13 reports
- MISSION 1610MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY2 recalls4 reports
- MISSION 1410MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall13 reports
- MISSION 1810MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall11 reports
- MISSION 1820MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall11 reports
- MISSION 2020MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall5 reports
- MISSION 1616MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2 reports
- MISSION 1825MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 report
- MISSION 1416MSKBard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall0 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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