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Recall Observatory FDA recall evidence

Device product

Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

Z-0027-2024

August 10, 2023

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 92994
Status
Ongoing
Classification
Class II
Quantity
1,545
Official record key
device-enforcement:Z-0027-2024

Official wording

Reason: 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.

Code information: UDI-DI: 00801741097393, Lot: 0001480774, Exp: 07/28/2025

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.