Recall Z-0027-2024— Bard Peripheral Vascular Inc

Name: FDA recall Z-0027-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-10

Class II · Ongoing

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2023-08-10. It names one FDA 510(k) clearance: K133948. Product: Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016. 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..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-08-10
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K133948 — BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENTBard Peripheral Vascular, Inc.·cleared 2014-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.