FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: 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.
- Recall number
- Z-0044-2018
- 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.
- Status
- Terminated
- Initiated
- 2017-09-22
- Posted
- not on file
- Terminated
- 2018-09-27
- 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.
- 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
- 110,550 units
- Distribution
- US, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K133948"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28