Z-0044-2018Class II

BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm...

Name: Z-0044-2018 BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm...
Creator: Bard Peripheral Vascular Inc
Published: 2017-09-22
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2017-09-22 / Terminated / root cause: design

FDA source

Bard Peripheral Vascular Inc began a recall of 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... on 2017-09-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0044-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-22
Posted: 2017-10-20
Terminated: 2018-09-27
Recalling firm: Bard Peripheral Vascular Inc
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.
Product code: KNW Instrument, Biopsy
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.
Root cause tag: design
FDA root cause: Device Design
Action: BPV sent a customer recall letter on September 22, 2017 to each of the US consignees via FedEx with proof of delivery notification. BPV will also initiate a recall for product outside the US in accordance with regulations of each country in which the product was distributed.
Quantity in commerce: 110,550 units
Distribution: US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
Product codes and lots: Lot Numbers: REBP0019, REBN0342, REBN2123, REBP1199, REBP1419, REBP1807, REBQ0084, REBQ0343, REBQ1012, REBP1420, REBP1809, REBP0869, REBP1266, REBP1267, REBP1421, REBP1422, REBP1810, REBQ0087, REBQ0088, REBQ0347, REBQ0811, REBQ1014, REBP0158, REBQ1904, REBQ1898, REBQ1978, REBR0468, REBQ2296, REBR0474

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0044-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0044-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-01	2017-10-20

Product code KNW

K133948Class IIBard(r) Monopty(r) Disposable Core Biopsy Instrument, Bard(r) Max-Core(r) Disposable Core InstrumentBard Peripheral Vascular, Inc. / cleared 2014-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)