Bard Peripheral Vascular Inc: Medical Device Recall in 2017 - (Recall #: Z-0044-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 22, 2017

Date Posted: November 1, 2017

Recall Number: Z-0044-2018

Event ID: 78224

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.

Status: Terminated

Product Quantity: 110,550 units

Code Information:

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

Distribution Pattern:

US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific

Voluntary or Mandated:

Voluntary: Firm initiated