Events

Recall of BARD MAXCORE Disposable Core Biopsy Instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Peripheral Vascular Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78224
  • Event Risk Class
    Class 2
  • Event Number
    Z-0044-2018
  • Event Initiated Date
    2017-09-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158919
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instrument, biopsy - Product Code KNW
  • Reason
    During the review of may 2017 complaint data, a significant increase in max-core disposable core biopsy instrument complaints was observed for failure to prime, failure to fire, failure to obtain sample, and self-activation.
  • Action
    BPV sent a customer recall letter on September 22, 2017 to each of the US consignees via FedEx with proof of delivery notification. BPV will also initiate a recall for product outside the US in accordance with regulations of each country in which the product was distributed.

Device

BARD MAXCORE Disposable Core Biopsy Instrument
  • Model / Serial
    Lot Numbers: REBP0019, REBN0342, REBN2123, REBP1199, REBP1419, REBP1807, REBQ0084, REBQ0343, REBQ1012, REBP1420, REBP1809, REBP0869, REBP1266, REBP1267, REBP1421, REBP1422, REBP1810, REBQ0087, REBQ0088, REBQ0347, REBQ0811, REBQ1014, REBP0158, REBQ1904, REBQ1898, REBQ1978, REBR0468, REBQ2296, REBR0474
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
  • Product Description
    BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. || The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St Bldg 1, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA