Skip to content

Bard Peripheral Vascular, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
39
FDA recalls
99 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue39

Newest first, rows 1-39 of 39

Search and filter all 39 devices
Skip device list

Rows 1-39 of 39

Company details

DUNS number
135057938
Website
bd.com
Phone
+1(800)321-4254

FDA recalls9

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 4
  • 2025 4
  • 2026 1

  • 2026

    • 20 Aug 2026 Z-3275-2026 Class II Ongoing Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy. Distribution: US Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC, ID, MI, KY, CT, IL, VA, MA, WI, NY, IN, TN,…
      Full distribution text US Nationwide distribution in the states of KS, SC, CA, TX, GA, NC, PA, SC, ID, MI, KY, CT, IL, VA, MA, WI, NY, IN, TN, OH, UT.
      Submission number: K252681

  • 2025

    • 12 Dec 2025 Z-1367-2026 Class II Ongoing Due to damage to outer tray that can potentially compromise the sterile barrier Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of 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, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.
      Submission numbers: K830233, K830256
    • 6 Nov 2025 Z-0887-2026 Class II Ongoing Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels. Distribution: US Nationwide distribution in the states of CA, MN, IN, MI, LA.
    • 21 Aug 2025 Z-2638-2025 Class II Ongoing Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation. Distribution: Worldwide - US Nationwide distribution including in the states of NJ, NY, FL, LA, VA, CA, TX, NV, PA, NE, TN, IL, AZ,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of NJ, NY, FL, LA, VA, CA, TX, NV, PA, NE, TN, IL, AZ, SC, AK, GA, CO, HI, OH, NC, WI, WV, MD, MO, AL, OK, MS, PR, KS, UT, CT, IA, MI, IN, MA, KY, WA, MT, MN, SD, ME, DE, NM, AR and the country of Malaysia.
      Submission numbers: K160754, K211806, K250068
    • 5 Feb 2025 Z-1244-2025 Class I Ongoing Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding. Distribution: US Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA, MS, MI, TX, KS, IL, CA, GA, OH, AL, NC, ND,…
      Full distribution text US Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA, MS, MI, TX, KS, IL, CA, GA, OH, AL, NC, ND, AZ, SC, TN, UT, AR, WI, SD, MA, MO, ME, DE, WV , NV, NH, MN, CT, NE, IA, NM, WA, HI, and OK
      Submission numbers: K172315, K211738, K242757

  • 2024

    • 30 Sep 2024 Z-0467-2025 Class II Ongoing 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. 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,…
      Full distribution text 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.
      Submission number: K133948
    • 4 Sep 2024 Z-0371-2025 Class II Ongoing The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Australia, Singapore, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Slovenia Spain, Sweden, Switzerland, United Kingdom, United Arab Emirates, and South Africa.
      Submission number: K160754
    • 2 Aug 2024 Z-3206-2024 Class II Ongoing Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised. Distribution: Worldwide - U.S. Nationwide distribution in the Puerto Rico and the countries of Canada, Pakistan, Peru, India,…
      Full distribution text Worldwide - U.S. Nationwide distribution in the Puerto Rico and the countries of Canada, Pakistan, Peru, India, Malaysia, China, Brazil, Mexico, Japan, Chile, Australia.
      Submission number: K934370
    • 10 Jul 2024 Z-3062-2024 Class II Ongoing Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient. Distribution: Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France,…
      Full distribution text Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom.
      Submission number: K770977

From the company website

Read 18 Oct 2026

At BD, we want to usher in a new era of healthcare by bringing medical products, capabilities and solutions to every corner of the world.

Translated from the manufacturer's own website. Source

Frequently asked questions

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

The registry currently lists 39 devices for Bard Peripheral Vascular, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bard Peripheral Vascular, Inc.'s devices?

Among its 39 most recently registered devices, Bard Peripheral Vascular, Inc. has devices listed in EUDAMED (3 devices), FDA 510(k) (34 devices), FDA PMA (5 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

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

Among its 39 most recently registered devices, the classes recorded for Bard Peripheral Vascular, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Bard Peripheral Vascular, Inc.?

FDA recall records list 9 recalls initiated by Bard Peripheral Vascular, Inc., the most recent initiated on 2026-08-20. 9 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, Inc. in the registry?

The most recently registered devices listed for Bard Peripheral Vascular, Inc. include PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE, TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM, UltraCor™ Twirl™ Breast Tissue Marker and Rotarex Atherectomy System.

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