Recall Z-0724-2020— Bard Peripheral Vascular Inc

Name: FDA recall Z-0724-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-25

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2019-10-25, terminated 2024-04-12. It names one FDA 510(k) clearance: K133948. Product: BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.. Reason: 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..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2019-10-25
Terminated: 2024-04-12
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 MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Reason for recall

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.

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