Recall Z-0044-2018— Bard Peripheral Vascular Inc

Name: FDA recall Z-0044-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-22

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2017-09-22, terminated 2018-09-27. It names one FDA 510(k) clearance: K133948. Product: 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.. 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..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2017-09-22
Terminated: 2018-09-27
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 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.

Reason for recall

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.

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