# FDA recall Z-1289-2021

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2021-01-14.

## Product

BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm  REF XXXXXXX    Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents

## Reason for recall

Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.

## Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH,  OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY    O.U.S.: Australia, Belgium, Canada, Europe, India, and Singapore

## Key facts

- **Recall number:** Z-1289-2021
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-14
- **Report date:** 2021-03-31
- **Termination date:** 2025-01-28

- **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-1289-2021

## Citation

> AI Analytics. FDA recall Z-1289-2021. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1289-2021. Source: US FDA. Licensed CC0.

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