Bard(R) Monopty(R) Disposable Core Biopsy Instrument, Bard(R) Max-Core(R) Disposable Core Instrument

• • Ongoing Z-0467-2025 FDA Class II ·initiated 30 Sep 2024

  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.

• • Ongoing Z-0027-2024 FDA Class II ·initiated 10 Aug 2023

  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.

• • Terminated Z-1289-2021 FDA Class II ·initiated 14 Jan 2021

  Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.

• • Terminated Z-0724-2020 FDA Class II ·initiated 25 Oct 2019

  During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.

• • Terminated Z-0044-2018 FDA Class II ·initiated 22 Sep 2017

  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.

• • Terminated Z-1586-2015 FDA Class II ·initiated 9 Apr 2015

  The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.

• • Terminated Z-1447-2015 FDA Class II ·initiated 17 Mar 2015

  Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.

510(k) Number

K133948 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Bard Peripheral Vascular, Inc. →