BARD MAX-CORE Disposable Core Biopsy Instrument — Class II medical device recall Z-0044-2018
Terminated recall by Bard Peripheral Vascular Inc, reported 2017-11-01. During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instru
| Recall number | Z-0044-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2017-09-22 |
| Classified | 2017-10-20 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2018-09-27 |
| Countries outside the US | AU, CA |
| Quantity | 110,550 units |
| Lot numbers | REBN0342, REBN2123, REBP0019, REBP0158, REBP0869, REBP1199, REBP1266, REBP1267, REBP1419, REBP1420, REBP1421, REBP1422, REBP1807, REBP1809, REBP1810, REBQ0084, REBQ0087, REBQ0088, REBQ0343, REBQ0347, REBQ0811, REBQ1012, REBQ1014, REBQ1898, REBQ1904, REBQ1978, REBQ2296, REBR0468, REBR0474 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0044-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.