# FDA recall Z-0044-2018

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2017-09-22.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0044-2018
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-22
- **Report date:** 2017-11-01
- **Termination date:** 2018-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0044-2018

## Citation

> AI Analytics. FDA recall Z-0044-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0044-2018. Source: US FDA. Licensed CC0.

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