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Bard Peripheral Vascular

Active in EUDAMED

Registered as Bard Peripheral Vascular, Inc. in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000017556 FEI 2020394

Bard Peripheral Vascular is a medical device manufacturer based in the United States, with 4,036 devices listed and 228 FDA recalls as of 14 Nov 2026.

Devices
4,036
Registrations
EUDAMEDFDA
FDA recalls
22823 ongoing since 2021 (28 open in total)
5 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 2,243
  • EUDAMED 2,167
  • FDA 510(k) 1
  • FDA PMA 1

Among the 3,000 best-ranked of 4,036 devices.

Device classes
  • FDA Class II 2,107
  • EU Class IIa 749
  • FDA Class III 120
  • FDA Class I 15
  • EU Class I 9

Among the 3,000 best-ranked of 4,036 devices.

Top EMDN categories

Among the 3,000 best-ranked of 4,036 devices.

FDA recalls
Identifiers
  • EUDAMED SRN US-MF-000017556
  • FDA FEI 2020394

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls

What Bard Peripheral Vascular makes

Bard Peripheral Vascular makes medical devices such as peripheral angioplasty balloon catheters, bare-metal biliary stents, peripheral artery stents, synthetic vascular grafts, and cardiovascular patches. Their products also include side-notch biopsy gun handpieces, cardiac valvuloplasty catheters, and vascular guide-catheters. Examples of their devices include the EleVation, Highlander, and LifeStar Vascular & Biliary Stent.

The company's portfolio is regulated under Class I, Class II, and Class III devices and is listed in the FDA UDI registry. The company is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4,036

Newest first, rows 1-50 of 4,036

Search and filter all 4,036 devices
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  • Ultraverse Ref U8100315

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U8752H6

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U815062

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U4200620

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US357586

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U4130630

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U81503H20

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U8100615

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U81002H4

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U41303H12

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U4200212

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U890225

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US141003H10

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US354082

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U42002H15

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US141003H6

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US14150625

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US357556

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US1410038

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U41301H8

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US1410046

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U810044

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dorado Ref DR8051H

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U82003H8

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U820028

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U410072

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U4100612

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U875725

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US3575425

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U4150320

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U4200515

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U4130615

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U810052

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U8100625

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U420054

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US1415056

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US3513046

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U81003H25

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U82002H30

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U410076

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US14100725

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US141003H4

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Dorado Ref DR13592

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U8503H4

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US3575610

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultrascore Ref US141003H15

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U875715

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U8200625

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U4130512

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultraverse Ref U875730

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Rows 1-50 of 4,036

Showing 1-50 of 4,036

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000017556
FDA FEI number
2020394
EUDAMED status
Active
EUDAMED registered name
Bard Peripheral Vascular, Inc.
Registered address
1625 W. 3rd Street, 85281, Tempe, United States
Website
bd.com
Phone
+1 (480) 894-9515
PRRC contact
Emily Harris(public in EUDAMED)

FDA recalls228

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 228 recalls initiated by Bard Peripheral Vascular, the earliest on 2003-08-20 and the most recent on 2023-11-14. By recorded status: 28 ongoing, 185 terminated and 15 with another status. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 2
  • 2018 17
  • 2019 51
  • 2020 10
  • 2021 10
  • 2022 13
  • 2023 6
  • 2024 0
  • 2025 0
  • 2026 0

119 initiated before 2017

Showing the 10 most recent of 228 recalls.

  • 2023

    • 14 Nov 2023 Z-0676-2024 Class II Ongoing Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking. Distribution: US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA,…
      Full distribution text US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA, NM, CO, KY, ME, MN
      Submission number: K203363
    • 8 Nov 2023 Z-0643-2024 Class II Ongoing 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. Distribution: Worldwide - US Nationwide distribution including in the states of PR, IL, MA, GA, KY, CA, TX, PA, IA, MN, NH, MD, FL,…
      Full distribution text 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.
      Submission number: K171953
    • 10 Aug 2023 Z-0027-2024 Class II Ongoing 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. 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,…
      Full distribution text 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.
      Submission number: K133948
    • 11 Apr 2023 Z-1564-2023 Class II Ongoing 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. 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,…
      Full distribution text 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
      Submission number: K171953
    • 28 Feb 2023 Z-1260-2023 Class II Ongoing The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility. Distribution: Worldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO, PA, TX, NC, CA, ME, MO, NV, MI, IL, NY, VA,…
      Full distribution text Worldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO, PA, TX, NC, CA, ME, MO, NV, MI, IL, NY, VA, AZ, NH, LA, WI, KY, MA, WA, CT, SD, OK, DC, IA, AR, GA, NE, NM, IN, NJ, MN, PR, AL, AK, SC, KS, OR, ID, VT, MT, WV, ND, TN, MS, HI, WY, RI and OUS countries of: Canada, Korea, Thailand and Taiwan. OUS: AR, AU, BE, CA, CN, CO, HK, IN, JP, KR, TH, TW
      Submission number: K171953
    • 4 Jan 2023 Z-1051-2023 Class II Ongoing Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable). Distribution: Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,…
      Full distribution text Worldwide Distribution: U.S.(nationwide): 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, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; OUS (foreign) countries of: Australia, Belgium, Canada, Hong Kong and Japan. O.U.S.: Australia, Belgium, Canada, Hong Kong, and Japan.
      Submission numbers: K830406, K871998

  • 2022

    • 22 Dec 2022 Z-1108-2023 Class II Ongoing An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, and WV the country of Canada.
    • 22 Apr 2022 Z-1273-2022 Class II Ongoing There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction. Distribution: Worldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA, CA, PA, AL,WA, TN, IN, NY and the countries of AU, BE, NZ.
    • 20 Jan 2022 Z-0790-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
    • 20 Jan 2022 Z-0791-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
Show the 25 most recent of 228 recalls

  • 2022

    • 20 Jan 2022 Z-0792-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
    • 20 Jan 2022 Z-0793-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
    • 20 Jan 2022 Z-0794-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
    • 20 Jan 2022 Z-0795-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
    • 20 Jan 2022 Z-0796-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
    • 20 Jan 2022 Z-0797-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
    • 20 Jan 2022 Z-0798-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
    • 20 Jan 2022 Z-0799-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
    • 20 Jan 2022 Z-0800-2022 Class II Ongoing Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Distribution: U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
      Full distribution text U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.

  • 2021

    • 24 Aug 2021 Z-0153-2022 Class II Terminated Due to misbranded products shipped to customers. Distribution: U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None Submission number: K171531
    • 24 Aug 2021 Z-0154-2022 Class II Terminated Due to misbranded products shipped to customers. Distribution: U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None Submission numbers: K171531, K913306
    • 27 Jul 2021 Z-0002-2022 Class II Ongoing Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV and the countries of Netherlands, United Arab Emirates, Australia, Taiwan, Asia, South Africa, Canada, JAPAN, India, Hong Kong, New Zealand, Mexico, China, Belgium, Malaysia, Singapore, Vietnam.
      Submission number: K930217
    • 23 Jun 2021 Z-2247-2021 Class II Ongoing Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. Distribution: U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia,…
      Full distribution text U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan
      Submission number: K171531
    • 23 Jun 2021 Z-2248-2021 Class II Ongoing Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. Distribution: U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia,…
      Full distribution text U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan
      Submission number: K171531
    • 23 Jun 2021 Z-2249-2021 Class II Ongoing Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. Distribution: U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia,…
      Full distribution text U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan
      Submission number: K930217

Frequently asked questions

How many devices does Bard Peripheral Vascular have in the registry?

The registry currently lists 4036 devices for Bard Peripheral Vascular. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bard Peripheral Vascular's devices?

Among its 50 most recently registered devices, Bard Peripheral Vascular has devices listed in EUDAMED (50 devices).

What risk classes do Bard Peripheral Vascular's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Bard Peripheral Vascular's devices are Class IIa. Each device page shows its own class and authorisation.

Are there FDA recall records for Bard Peripheral Vascular?

FDA recall records list 228 recalls initiated by Bard Peripheral Vascular, the most recent initiated on 14 Nov 2023. 28 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Bard Peripheral Vascular in the registry?

The most recently registered devices listed for Bard Peripheral Vascular include ULTRAVERSE, ULTRASCORE and DORADO.

Generated automatically from registry data and not verified by a human reviewer.